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.
Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- radiation: intensity-modulated radiation therapy
Eligibility
INCLUSION CRITERIA:
- Histologically or cytologically confirmed non-hematopoietic malignancy within the past
5 years
- If histologic proof of malignancy is from > 5 years ago, then a more recent
pathological confirmation is required (e.g., from systemic metastatic or brain
metastasis)
- Patients with metastasis of unknown primary tumor are permitted
- Measurable brain metastasis outside a 5-mm margin around either hippocampus on
gadolinium contrast-enhanced MRI obtained within the past 30 days
- Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical
resection
- These treatment options are allowed only at relapse
- Patients who have brain metastases at initial presentation allowed and do not need to
demonstrate 3 months of stable scans
- At least 1 week since open biopsy
- Karnofsky performance status 70-100%
- Fertile patients must use effective contraception
- Negative pregnancy test 2 weeks or less prior to study entry
- Patients must be English proficient, with patients who speak English as a second
language eligible
EXCLUSION CRITERIA:
- Small cell lung cancer or germ cell malignancy
- Leptomeningeal metastases
- Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of
extracranial metastases
- Radiologic evidence of hydrocephalus
- Serum creatinine > 1.4 mg/dL within 30 days prior to study entry
- Pregnant or nursing
- Contraindication to MRI imaging such as implanted metal devices or foreign bodies or
severe claustrophobia
- Severe, active co-morbidity including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy
- Uncontrolled, clinically significant cardiac arrhythmias
- Prior radiotherapy to the brain
- Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7
days
Ages Eligible for Study
18 Years - 120 Years
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
Jacob Wynne
6507238843
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.