Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
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.
Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work better by making tumor cells more sensitive to the drugs. It may also make tumor cells more sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin, fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of 11/3/2008) or stage III anal cancer.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: cetuximab
- drug: fluorouracil
- drug: cisplatin
- radiation: radiotherapy
Eligibility
INCLUSION CRITERIA:
- Histologically confirmed anal canal or perianal (anal margin) squamous cell carcinoma
- Stage I-IIIB (closed to accrual as of 11/3/2008)
- Stage II (T3, N0 only), IIIA, or IIIB
- Tumors of nonkeratinizing histology, such as basaloid, transitional cell, or
cloacogenic histology, allowed
- No well-differentiated stage I anal margin cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 100,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 60 mL/min
- Bilirubin ≤ 2 times ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment
- No other malignancies except nonmelanomatous skin cancer
- Prior malignancies must be in remission for ≥ 5 years
- Patients with a known risk factor for human immunodeficiency virus (HIV) infection
must undergo HIV testing within 90 days before study entry AND must be HIV negative by
antibody detection, culture, or quantitative assay of plasma HIV ribonucleic acid
(RNA)
EXCLUSION CRITERIA:
- Presence of the following conditions within the past 6 months:
- Active infection
- Uncontrolled diabetes
- New York Heart Association class II-IV congestive heart failure
- Cerebrovascular accident
- Transient ischemic attack
- Uncontrolled hypertension
- Unstable angina
- Myocardial infarction
- History of rheumatic disorders, irritable bowel syndrome, or inflammatory bowel
disease
- Known HIV positivity
- Known risk factors for HIV infection
- Prior radiotherapy or chemotherapy for this malignancy
- Prior pelvic radiotherapy
- Prior potentially curative surgery (i.e., abdominal or peritoneal resection) for anal
cancer
- Pregnant or nursing
Ages Eligible for Study
18 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
CCTO
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.