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.
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.
After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- radiation: Vaginal Cuff Brachytherapy
- radiation: Short course vaginal cuff brachytherapy
Eligibility
Inclusion Criteria:
- Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear
cell, to include tumors originating in the cervix, but are primarily located in the
uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other
sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I, with
one of the following combinations of stage and grade:
- Stage IA, grade 2, 3
- Stage IB, grades 1-3
- Stage II, grades 1-3
- Participants post hysterectomy and free from residual disease
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance
status 0-2
- Able to provide informed consent and willing to sign an approved consent form that
conforms to federal and institutional guidelines
- Life expectancy of >2 years.
Exclusion Criteria:
- Stages of endometrial carcinoma other than described
- Previous pelvic radiotherapy
- Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
Ages Eligible for Study
N/A - 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
Akschy Peer
650-736-0792
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.