Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cisplatin
- drug: Cisplatin
- other: Quality-of-Life Assessment
- other: Questionnaire Administration
- radiation: Radiation Therapy
Eligibility
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the
oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to
registration; specimen from cervical lymph nodes with a well-defined primary site
documented clinically or radiologically is acceptable; in patients with carcinoma of
unknown primary this will be sufficient for pathologic confirmation without a
clinically or radiographically defined primary site
- For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell
block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole
diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
- Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC)
in order to be eligible for the trial using a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process
similar to the United States (U.S.) CLIA certification, such as the provincial
accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in
Canada, the College of American Pathologists (CAP), or an equivalent accreditation in
other countries, is acceptable.
- The p16 results must be reported on the pathology report being submitted. The p16
positivity is defined as > 70% of tumor cells showing strong nuclear and/or
cytoplasmic immunostaining with p16 antibody.
- For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status
is NOT required
- Patients must have clinically or radiographically evident measurable disease
at the primary site or at nodal stations. Simple tonsillectomy or local
excision of the primary without removal of nodal disease is permitted, as is
excision removing gross nodal disease but with intact primary site. Limited
neck dissections retrieving =< 4 nodes are permitted and considered as
non-therapeutic nodal excisions
- Clinical stage (American Joint Committee on Cancer [AJCC], 8th ed.),
including no distant metastases based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration
- One of the following imaging studies is required within 60 days prior to
registration:
- Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless
contraindicated) OR
- Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless
contraindicated) OR
- Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT
component must be of diagnostic quality with contrast, unless contraindicated.
- Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck
performed for the purposes of radiation planning may serve as both staging and
planning tools
- One of the following imaging studies is required within 60 days prior to
registration:
- FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended
to be used for eligibility OR
- Chest CT
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable)
within 70 days prior to registration;
- Eligibility by patient cohort;
- Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging
(AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
- Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3,
or T3-4 N0-1
- p16-positive OPC/CUP Cohort;
- Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1-3 N2-3 or T4 N0-3
- Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1N2-3, T2N1-3 or T3-4 N0-3
- Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime
pack-years. Marijuana consumption is likewise not considered in this calculation. There is
also no clear scientific evidence regarding the role of chewing tobacco-containing products
in oropharyngeal cancer, although this is possibly more concerning given the proximity of
the oral cavity and oropharynx. In any case, investigators should not count use of
non-cigarette tobacco products in the pack-years calculation.
- Age >= 18
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14
days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to
registration)
- Platelets >= 75,000 cells/mm^3 (within 30 days prior to registration)
- Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
- Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >=
8.0 g/dL is acceptable)
- Calculated creatinine clearance (CrCl) >= 50 mL/min by the Cockcroft-Gault formula
(within 30 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days
prior to registration) (not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x
institutional ULN (within 30 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective
anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell
count > 200 cells/mm^3 are eligible for this trial. Testing is not required for entry
into protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically
as 12 months of amenorrhea in a woman over 45 in the absence of other biological or
physiological causes
- Willing to use highly effective contraceptives for participants of childbearing
potential (participants who may become pregnant or who may impregnate a partner)
during therapy and for 14 months (females); for 11 months (males) following last dose
of cisplatin; this inclusion is necessary because the treatment in this study may be
significantly teratogenic
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of
unknown primary (CUP)
- Recurrence of the study cancer
- Definitive clinical or radiologic evidence of distant metastatic disease
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable, however, any prior exposure to cisplatin is excluded
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
- New York Heart Association Functional Classification III/IV (Note: Patients with
known history or current symptoms of cardiac disease, or history of treatment
with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be
reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics prior to
registration;
- Other chronic renal disease like nephrotic syndrome, that could be worsened by
cisplatin therapy
- History of allogenic organ transplantation
- Any symptomatic peripheral sensory neuropathy grade >= 2 (CTCAE version 5.0);
- Pregnancy and individuals unwilling to discontinue nursing
- History of hypersensitivity to cisplatin or platinum-containing compounds
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Site Public Contact
650-498-7061
I'm interested
Psoriasis Clinical Trials
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cisplatin
- drug: Cisplatin
- other: Quality-of-Life Assessment
- other: Questionnaire Administration
- radiation: Radiation Therapy
Eligibility
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the
oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to
registration; specimen from cervical lymph nodes with a well-defined primary site
documented clinically or radiologically is acceptable; in patients with carcinoma of
unknown primary this will be sufficient for pathologic confirmation without a
clinically or radiographically defined primary site
- For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell
block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole
diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
- Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC)
in order to be eligible for the trial using a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process
similar to the United States (U.S.) CLIA certification, such as the provincial
accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in
Canada, the College of American Pathologists (CAP), or an equivalent accreditation in
other countries, is acceptable.
- The p16 results must be reported on the pathology report being submitted. The p16
positivity is defined as > 70% of tumor cells showing strong nuclear and/or
cytoplasmic immunostaining with p16 antibody.
- For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status
is NOT required
- Patients must have clinically or radiographically evident measurable disease
at the primary site or at nodal stations. Simple tonsillectomy or local
excision of the primary without removal of nodal disease is permitted, as is
excision removing gross nodal disease but with intact primary site. Limited
neck dissections retrieving =< 4 nodes are permitted and considered as
non-therapeutic nodal excisions
- Clinical stage (American Joint Committee on Cancer [AJCC], 8th ed.),
including no distant metastases based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration
- One of the following imaging studies is required within 60 days prior to
registration:
- Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless
contraindicated) OR
- Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless
contraindicated) OR
- Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT
component must be of diagnostic quality with contrast, unless contraindicated.
- Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck
performed for the purposes of radiation planning may serve as both staging and
planning tools
- One of the following imaging studies is required within 60 days prior to
registration:
- FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended
to be used for eligibility OR
- Chest CT
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable)
within 70 days prior to registration;
- Eligibility by patient cohort;
- Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging
(AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
- Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3,
or T3-4 N0-1
- p16-positive OPC/CUP Cohort;
- Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1-3 N2-3 or T4 N0-3
- Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1N2-3, T2N1-3 or T3-4 N0-3
- Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime
pack-years. Marijuana consumption is likewise not considered in this calculation. There is
also no clear scientific evidence regarding the role of chewing tobacco-containing products
in oropharyngeal cancer, although this is possibly more concerning given the proximity of
the oral cavity and oropharynx. In any case, investigators should not count use of
non-cigarette tobacco products in the pack-years calculation.
- Age >= 18
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14
days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to
registration)
- Platelets >= 75,000 cells/mm^3 (within 30 days prior to registration)
- Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
- Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >=
8.0 g/dL is acceptable)
- Calculated creatinine clearance (CrCl) >= 50 mL/min by the Cockcroft-Gault formula
(within 30 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days
prior to registration) (not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x
institutional ULN (within 30 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective
anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell
count > 200 cells/mm^3 are eligible for this trial. Testing is not required for entry
into protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically
as 12 months of amenorrhea in a woman over 45 in the absence of other biological or
physiological causes
- Willing to use highly effective contraceptives for participants of childbearing
potential (participants who may become pregnant or who may impregnate a partner)
during therapy and for 14 months (females); for 11 months (males) following last dose
of cisplatin; this inclusion is necessary because the treatment in this study may be
significantly teratogenic
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of
unknown primary (CUP)
- Recurrence of the study cancer
- Definitive clinical or radiologic evidence of distant metastatic disease
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable, however, any prior exposure to cisplatin is excluded
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
- New York Heart Association Functional Classification III/IV (Note: Patients with
known history or current symptoms of cardiac disease, or history of treatment
with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be
reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics prior to
registration;
- Other chronic renal disease like nephrotic syndrome, that could be worsened by
cisplatin therapy
- History of allogenic organ transplantation
- Any symptomatic peripheral sensory neuropathy grade >= 2 (CTCAE version 5.0);
- Pregnancy and individuals unwilling to discontinue nursing
- History of hypersensitivity to cisplatin or platinum-containing compounds
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Site Public Contact
650-498-7061
I'm interested
Dermatology Clinical Trials
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cisplatin
- drug: Cisplatin
- other: Quality-of-Life Assessment
- other: Questionnaire Administration
- radiation: Radiation Therapy
Eligibility
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the
oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to
registration; specimen from cervical lymph nodes with a well-defined primary site
documented clinically or radiologically is acceptable; in patients with carcinoma of
unknown primary this will be sufficient for pathologic confirmation without a
clinically or radiographically defined primary site
- For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell
block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole
diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
- Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC)
in order to be eligible for the trial using a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process
similar to the United States (U.S.) CLIA certification, such as the provincial
accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in
Canada, the College of American Pathologists (CAP), or an equivalent accreditation in
other countries, is acceptable.
- The p16 results must be reported on the pathology report being submitted. The p16
positivity is defined as > 70% of tumor cells showing strong nuclear and/or
cytoplasmic immunostaining with p16 antibody.
- For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status
is NOT required
- Patients must have clinically or radiographically evident measurable disease
at the primary site or at nodal stations. Simple tonsillectomy or local
excision of the primary without removal of nodal disease is permitted, as is
excision removing gross nodal disease but with intact primary site. Limited
neck dissections retrieving =< 4 nodes are permitted and considered as
non-therapeutic nodal excisions
- Clinical stage (American Joint Committee on Cancer [AJCC], 8th ed.),
including no distant metastases based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration
- One of the following imaging studies is required within 60 days prior to
registration:
- Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless
contraindicated) OR
- Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless
contraindicated) OR
- Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT
component must be of diagnostic quality with contrast, unless contraindicated.
- Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck
performed for the purposes of radiation planning may serve as both staging and
planning tools
- One of the following imaging studies is required within 60 days prior to
registration:
- FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended
to be used for eligibility OR
- Chest CT
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable)
within 70 days prior to registration;
- Eligibility by patient cohort;
- Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging
(AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
- Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3,
or T3-4 N0-1
- p16-positive OPC/CUP Cohort;
- Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1-3 N2-3 or T4 N0-3
- Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1N2-3, T2N1-3 or T3-4 N0-3
- Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime
pack-years. Marijuana consumption is likewise not considered in this calculation. There is
also no clear scientific evidence regarding the role of chewing tobacco-containing products
in oropharyngeal cancer, although this is possibly more concerning given the proximity of
the oral cavity and oropharynx. In any case, investigators should not count use of
non-cigarette tobacco products in the pack-years calculation.
- Age >= 18
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14
days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to
registration)
- Platelets >= 75,000 cells/mm^3 (within 30 days prior to registration)
- Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
- Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >=
8.0 g/dL is acceptable)
- Calculated creatinine clearance (CrCl) >= 50 mL/min by the Cockcroft-Gault formula
(within 30 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days
prior to registration) (not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x
institutional ULN (within 30 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective
anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell
count > 200 cells/mm^3 are eligible for this trial. Testing is not required for entry
into protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically
as 12 months of amenorrhea in a woman over 45 in the absence of other biological or
physiological causes
- Willing to use highly effective contraceptives for participants of childbearing
potential (participants who may become pregnant or who may impregnate a partner)
during therapy and for 14 months (females); for 11 months (males) following last dose
of cisplatin; this inclusion is necessary because the treatment in this study may be
significantly teratogenic
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of
unknown primary (CUP)
- Recurrence of the study cancer
- Definitive clinical or radiologic evidence of distant metastatic disease
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable, however, any prior exposure to cisplatin is excluded
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
- New York Heart Association Functional Classification III/IV (Note: Patients with
known history or current symptoms of cardiac disease, or history of treatment
with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be
reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics prior to
registration;
- Other chronic renal disease like nephrotic syndrome, that could be worsened by
cisplatin therapy
- History of allogenic organ transplantation
- Any symptomatic peripheral sensory neuropathy grade >= 2 (CTCAE version 5.0);
- Pregnancy and individuals unwilling to discontinue nursing
- History of hypersensitivity to cisplatin or platinum-containing compounds
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Site Public Contact
650-498-7061
I'm interested
Pediatric Dermatology Clinical Trials
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cisplatin
- drug: Cisplatin
- other: Quality-of-Life Assessment
- other: Questionnaire Administration
- radiation: Radiation Therapy
Eligibility
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the
oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to
registration; specimen from cervical lymph nodes with a well-defined primary site
documented clinically or radiologically is acceptable; in patients with carcinoma of
unknown primary this will be sufficient for pathologic confirmation without a
clinically or radiographically defined primary site
- For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell
block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole
diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
- Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC)
in order to be eligible for the trial using a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process
similar to the United States (U.S.) CLIA certification, such as the provincial
accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in
Canada, the College of American Pathologists (CAP), or an equivalent accreditation in
other countries, is acceptable.
- The p16 results must be reported on the pathology report being submitted. The p16
positivity is defined as > 70% of tumor cells showing strong nuclear and/or
cytoplasmic immunostaining with p16 antibody.
- For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status
is NOT required
- Patients must have clinically or radiographically evident measurable disease
at the primary site or at nodal stations. Simple tonsillectomy or local
excision of the primary without removal of nodal disease is permitted, as is
excision removing gross nodal disease but with intact primary site. Limited
neck dissections retrieving =< 4 nodes are permitted and considered as
non-therapeutic nodal excisions
- Clinical stage (American Joint Committee on Cancer [AJCC], 8th ed.),
including no distant metastases based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration
- One of the following imaging studies is required within 60 days prior to
registration:
- Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless
contraindicated) OR
- Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless
contraindicated) OR
- Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT
component must be of diagnostic quality with contrast, unless contraindicated.
- Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck
performed for the purposes of radiation planning may serve as both staging and
planning tools
- One of the following imaging studies is required within 60 days prior to
registration:
- FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended
to be used for eligibility OR
- Chest CT
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable)
within 70 days prior to registration;
- Eligibility by patient cohort;
- Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging
(AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
- Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3,
or T3-4 N0-1
- p16-positive OPC/CUP Cohort;
- Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1-3 N2-3 or T4 N0-3
- Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1N2-3, T2N1-3 or T3-4 N0-3
- Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime
pack-years. Marijuana consumption is likewise not considered in this calculation. There is
also no clear scientific evidence regarding the role of chewing tobacco-containing products
in oropharyngeal cancer, although this is possibly more concerning given the proximity of
the oral cavity and oropharynx. In any case, investigators should not count use of
non-cigarette tobacco products in the pack-years calculation.
- Age >= 18
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14
days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to
registration)
- Platelets >= 75,000 cells/mm^3 (within 30 days prior to registration)
- Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
- Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >=
8.0 g/dL is acceptable)
- Calculated creatinine clearance (CrCl) >= 50 mL/min by the Cockcroft-Gault formula
(within 30 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days
prior to registration) (not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x
institutional ULN (within 30 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective
anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell
count > 200 cells/mm^3 are eligible for this trial. Testing is not required for entry
into protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically
as 12 months of amenorrhea in a woman over 45 in the absence of other biological or
physiological causes
- Willing to use highly effective contraceptives for participants of childbearing
potential (participants who may become pregnant or who may impregnate a partner)
during therapy and for 14 months (females); for 11 months (males) following last dose
of cisplatin; this inclusion is necessary because the treatment in this study may be
significantly teratogenic
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of
unknown primary (CUP)
- Recurrence of the study cancer
- Definitive clinical or radiologic evidence of distant metastatic disease
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable, however, any prior exposure to cisplatin is excluded
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
- New York Heart Association Functional Classification III/IV (Note: Patients with
known history or current symptoms of cardiac disease, or history of treatment
with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be
reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics prior to
registration;
- Other chronic renal disease like nephrotic syndrome, that could be worsened by
cisplatin therapy
- History of allogenic organ transplantation
- Any symptomatic peripheral sensory neuropathy grade >= 2 (CTCAE version 5.0);
- Pregnancy and individuals unwilling to discontinue nursing
- History of hypersensitivity to cisplatin or platinum-containing compounds
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Site Public Contact
650-498-7061
I'm interested
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cisplatin
- drug: Cisplatin
- other: Quality-of-Life Assessment
- other: Questionnaire Administration
- radiation: Radiation Therapy
Eligibility
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the
oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to
registration; specimen from cervical lymph nodes with a well-defined primary site
documented clinically or radiologically is acceptable; in patients with carcinoma of
unknown primary this will be sufficient for pathologic confirmation without a
clinically or radiographically defined primary site
- For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell
block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole
diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
- Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC)
in order to be eligible for the trial using a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process
similar to the United States (U.S.) CLIA certification, such as the provincial
accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in
Canada, the College of American Pathologists (CAP), or an equivalent accreditation in
other countries, is acceptable.
- The p16 results must be reported on the pathology report being submitted. The p16
positivity is defined as > 70% of tumor cells showing strong nuclear and/or
cytoplasmic immunostaining with p16 antibody.
- For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status
is NOT required
- Patients must have clinically or radiographically evident measurable disease
at the primary site or at nodal stations. Simple tonsillectomy or local
excision of the primary without removal of nodal disease is permitted, as is
excision removing gross nodal disease but with intact primary site. Limited
neck dissections retrieving =< 4 nodes are permitted and considered as
non-therapeutic nodal excisions
- Clinical stage (American Joint Committee on Cancer [AJCC], 8th ed.),
including no distant metastases based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration
- One of the following imaging studies is required within 60 days prior to
registration:
- Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless
contraindicated) OR
- Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless
contraindicated) OR
- Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT
component must be of diagnostic quality with contrast, unless contraindicated.
- Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck
performed for the purposes of radiation planning may serve as both staging and
planning tools
- One of the following imaging studies is required within 60 days prior to
registration:
- FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended
to be used for eligibility OR
- Chest CT
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable)
within 70 days prior to registration;
- Eligibility by patient cohort;
- Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging
(AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
- Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3,
or T3-4 N0-1
- p16-positive OPC/CUP Cohort;
- Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1-3 N2-3 or T4 N0-3
- Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1N2-3, T2N1-3 or T3-4 N0-3
- Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime
pack-years. Marijuana consumption is likewise not considered in this calculation. There is
also no clear scientific evidence regarding the role of chewing tobacco-containing products
in oropharyngeal cancer, although this is possibly more concerning given the proximity of
the oral cavity and oropharynx. In any case, investigators should not count use of
non-cigarette tobacco products in the pack-years calculation.
- Age >= 18
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14
days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to
registration)
- Platelets >= 75,000 cells/mm^3 (within 30 days prior to registration)
- Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
- Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >=
8.0 g/dL is acceptable)
- Calculated creatinine clearance (CrCl) >= 50 mL/min by the Cockcroft-Gault formula
(within 30 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days
prior to registration) (not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x
institutional ULN (within 30 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective
anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell
count > 200 cells/mm^3 are eligible for this trial. Testing is not required for entry
into protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically
as 12 months of amenorrhea in a woman over 45 in the absence of other biological or
physiological causes
- Willing to use highly effective contraceptives for participants of childbearing
potential (participants who may become pregnant or who may impregnate a partner)
during therapy and for 14 months (females); for 11 months (males) following last dose
of cisplatin; this inclusion is necessary because the treatment in this study may be
significantly teratogenic
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of
unknown primary (CUP)
- Recurrence of the study cancer
- Definitive clinical or radiologic evidence of distant metastatic disease
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable, however, any prior exposure to cisplatin is excluded
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
- New York Heart Association Functional Classification III/IV (Note: Patients with
known history or current symptoms of cardiac disease, or history of treatment
with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be
reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics prior to
registration;
- Other chronic renal disease like nephrotic syndrome, that could be worsened by
cisplatin therapy
- History of allogenic organ transplantation
- Any symptomatic peripheral sensory neuropathy grade >= 2 (CTCAE version 5.0);
- Pregnancy and individuals unwilling to discontinue nursing
- History of hypersensitivity to cisplatin or platinum-containing compounds
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Site Public Contact
650-498-7061
I'm interested
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cisplatin
- drug: Cisplatin
- other: Quality-of-Life Assessment
- other: Questionnaire Administration
- radiation: Radiation Therapy
Eligibility
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the
oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to
registration; specimen from cervical lymph nodes with a well-defined primary site
documented clinically or radiologically is acceptable; in patients with carcinoma of
unknown primary this will be sufficient for pathologic confirmation without a
clinically or radiographically defined primary site
- For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell
block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole
diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
- Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC)
in order to be eligible for the trial using a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process
similar to the United States (U.S.) CLIA certification, such as the provincial
accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in
Canada, the College of American Pathologists (CAP), or an equivalent accreditation in
other countries, is acceptable.
- The p16 results must be reported on the pathology report being submitted. The p16
positivity is defined as > 70% of tumor cells showing strong nuclear and/or
cytoplasmic immunostaining with p16 antibody.
- For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status
is NOT required
- Patients must have clinically or radiographically evident measurable disease
at the primary site or at nodal stations. Simple tonsillectomy or local
excision of the primary without removal of nodal disease is permitted, as is
excision removing gross nodal disease but with intact primary site. Limited
neck dissections retrieving =< 4 nodes are permitted and considered as
non-therapeutic nodal excisions
- Clinical stage (American Joint Committee on Cancer [AJCC], 8th ed.),
including no distant metastases based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration
- One of the following imaging studies is required within 60 days prior to
registration:
- Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless
contraindicated) OR
- Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless
contraindicated) OR
- Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT
component must be of diagnostic quality with contrast, unless contraindicated.
- Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck
performed for the purposes of radiation planning may serve as both staging and
planning tools
- One of the following imaging studies is required within 60 days prior to
registration:
- FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended
to be used for eligibility OR
- Chest CT
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable)
within 70 days prior to registration;
- Eligibility by patient cohort;
- Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging
(AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
- Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3,
or T3-4 N0-1
- p16-positive OPC/CUP Cohort;
- Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1-3 N2-3 or T4 N0-3
- Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical Staging (AJCC, 8th
ed.): T1N2-3, T2N1-3 or T3-4 N0-3
- Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime
pack-years. Marijuana consumption is likewise not considered in this calculation. There is
also no clear scientific evidence regarding the role of chewing tobacco-containing products
in oropharyngeal cancer, although this is possibly more concerning given the proximity of
the oral cavity and oropharynx. In any case, investigators should not count use of
non-cigarette tobacco products in the pack-years calculation.
- Age >= 18
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14
days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to
registration)
- Platelets >= 75,000 cells/mm^3 (within 30 days prior to registration)
- Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
- Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >=
8.0 g/dL is acceptable)
- Calculated creatinine clearance (CrCl) >= 50 mL/min by the Cockcroft-Gault formula
(within 30 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days
prior to registration) (not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x
institutional ULN (within 30 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective
anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell
count > 200 cells/mm^3 are eligible for this trial. Testing is not required for entry
into protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically
as 12 months of amenorrhea in a woman over 45 in the absence of other biological or
physiological causes
- Willing to use highly effective contraceptives for participants of childbearing
potential (participants who may become pregnant or who may impregnate a partner)
during therapy and for 14 months (females); for 11 months (males) following last dose
of cisplatin; this inclusion is necessary because the treatment in this study may be
significantly teratogenic
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of
unknown primary (CUP)
- Recurrence of the study cancer
- Definitive clinical or radiologic evidence of distant metastatic disease
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable, however, any prior exposure to cisplatin is excluded
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
- New York Heart Association Functional Classification III/IV (Note: Patients with
known history or current symptoms of cardiac disease, or history of treatment
with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be
reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics prior to
registration;
- Other chronic renal disease like nephrotic syndrome, that could be worsened by
cisplatin therapy
- History of allogenic organ transplantation
- Any symptomatic peripheral sensory neuropathy grade >= 2 (CTCAE version 5.0);
- Pregnancy and individuals unwilling to discontinue nursing
- History of hypersensitivity to cisplatin or platinum-containing compounds
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Site Public Contact
650-498-7061
I'm interested