Jeffrey Norton
Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: Capecitabine (Xeloda)
- Drug: Oxaliplatin (Eloxatin)
- Procedure: Radiation therapy
- Procedure: Surgery
Phase:
Phase 1Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus by pathologist.
- Endoscopic ultrasound or CT evidence of tumor penetration through the esophageal wall or involvement of regional lymph nodes, without evidence of distant metastasis
- No prior chest radiation therapy
- No prior chemotherapy for esophageal cancer
- Age greater than 18 years
- No infections requiring antibiotic treatment
- Able to care for self
- Patients must have acceptable liver, kidney and bone marrow function.
- The effects of the chemotherapy drugs on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception.
Key Exclusion Criteria:
- Patients receiving any other investigational agents
- Evidence of distant metastases
- Uncontrolled medical illness
- Any malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
- Pregnant and breastfeeding women are excluded.
- HIV-positive patients
Additional Study Details
Official Title:
Phase I Study of Dose Escalation Using Image-guided Radiotherapy to Deliver a Stereotactic Radiosurgical Boost after Neoadjuvant Chemoradiotherapy in Patients with Locally Advanced Esophageal CancerAnticipated start date:
6/6/2006Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.
- The inked margins on the definitive surgical specimen will be inked and margin status, size of the tumor, evidence of residual tumor will be recorded.
- Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation.
Secondary Outcomes:
- Upper endoscopy: Three months after completion of therapy, then every six months for three years then once a year for until 5 years from completion of therapy.
- Patterns of failure and the 2-year progression-free survival (PFS) rate.
- Physical exam: Once every three months for two years, then every six months for three years and then once a year.
- CT scans: Three months after completion of therapy, then every six months for three years then once a year for until 5 years from completion of therapy.
Total Number to be Enrolled:
35Total Number to be Enrolled at Stanford:
35More Information
Secondary ID(s):
- 96075
- ESOPH0001
- NCT00368329
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/15/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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