Stanford APBI Trial
Clinical Trial
Overview
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: TH-302 in Combination with Doxorubicin
- drug: Doxorubicin
Eligibility
Inclusion Criteria:
- Male or female ≥ 15 years of age
- Ability to understand the purposes and risks of the study and has signed or, if
appropriate, the subject's parent or legal guardian has signed a written informed
consent form approved by the investigator's IRB/Ethics Committee
- Pathologically confirmed diagnosis of soft tissue sarcoma of the following
histopathologic types:
- Synovial sarcoma
- High grade fibrosarcoma
- Undifferentiated sarcoma; sarcoma not otherwise specified (NOS)
- Liposarcoma
- Leiomyosarcoma (excluding GIST)
- Angiosarcoma (excluding Kaposi's sarcoma)
- Malignant peripheral nerve sheath tumor
- Pleomorphic Rhabdomyosarcoma
- Myxofibrosarcoma
- Epithelioid sarcoma
- Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (MFH)
(including pleomorphic, giant cell, myxoid and inflammatory forms)
- Locally advanced unresectable or metastatic disease with no standard curative therapy
available and for whom treatment with single agent doxorubicin is considered
appropriate.
- Recovered from reversible toxicities of prior therapy
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Acceptable liver, renal, hematological and cardiac function
- All women of childbearing potential must have a negative serum pregnancy test and all
subjects must agree to use effective means of contraception
Exclusion Criteria:
- Prior systemic therapy for advanced or metastatic disease (neoadjuvant therapy
followed by surgical resection and adjuvant therapy permitted). Palliative
radiotherapy to non-target lesions is allowed if completed at least two weeks prior to
study entry
- Low grade tumors according to standard grading systems
- Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards
- Prior therapy with an anthracycline or anthracenedione
- Prior mediastinal/cardiac radiotherapy
- Current use of drugs with known cardiotoxicity or known interactions with doxorubicin
- Anti-cancer treatment with radiation therapy, neoadjuvant or adjuvant chemotherapy,
targeted therapies, immunotherapy, hormones or other antitumor therapies within 4
weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Palliative
radiotherapy to non-target lesions is allowed, is completed at least two weeks prior
to study entry.
- Significant cardiac dysfunction precluding treatment with doxorubicin
- Seizure disorders requiring anticonvulsant therapy unless seizure-free for the last
year
- Known brain metastases (unless previously treated and well controlled for a period of
≥ 3 months)
- Previously treated malignancies, except for adequately treated non-melanoma skin
cancer, in situ cancer, or other cancer from which the subject has been disease-free
for at least 5 years
- Severe chronic obstructive or other pulmonary disease with hypoxemia or in the opinion
of the investigator any physiological state likely to cause normal tissue hypoxia
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without
complete recovery
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy
- Prior therapy with a hypoxic cytotoxin
- Subjects who participated in an investigational drug or device study within 28 days
prior to study entry
- Known infection with HIV, hepatitis B, or hepatitis C
- Subjects who have exhibited allergic reactions to a structural compound similar to
TH-302,doxorubicin or their excipients
- Females who are pregnant or breast-feeding
- Concomitant disease or condition that could interfere with the conduct of the study,
or that would, in the opinion of the investigator, pose an unacceptable risk to the
subject in this study
- Unwillingness or inability to comply with the study protocol for any reason
Ages Eligible for Study
15 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.