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.
The Myelin Disorders Biorepository Project
The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects. The MDBP is one of the world's largest leukodystrophy biorepositories, having enrolled nearly 2,000 affected individuals since it was launched over a decade ago.
Researchers working in the biorepository hope to use these materials to uncover new genetic etiologies for various leukodystrophies, develop biomarkers for use in future clinical trials, and better understand the natural history of these disorders. The knowledge gained from these efforts may help improve the diagnostic tools and treatment options available to patients in the future.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Eligibility
Inclusion Criteria (Affected Subjects):
- Male or female of any age;
- Suspected or confirmed diagnosis of leukodystrophy or other disorder affecting the
white matter of the brain based primarily on the finding of central nervous system
neuroimaging consistent with this diagnosis or on an existing diagnosis of a
leukodystrophy or genetic leukoencephalopathy as defined in existing classification
systems;
- Documentation of informed consent by the subject, parent, or legal guardian, and, if
appropriate, documentation of assent;
- Willingness to provide clinical data, participate in standardized assessments, and/or
provide biologic samples.
Exclusion Criteria (Affected Subjects)
- Established diagnosis at the time of referral that is not consistent with a genetic
disorder of the white matter, such as an acquired demyelinating condition (e.g.
multiple sclerosis), or an infectious etiology, with the exception of sequelae of
congenital infections such as CMV;
- Inability to provide consent.
Inclusion Criteria (Healthy Controls)
- Male or female of any age;
- Individuals with no confirmed or suspected diagnosis of leukodystrophy or other
disorder affecting the white matter of the brain;
- Documentation of informed consent by the subject, parent, or legal guardian, and, if
appropriate, documentation of assent.
Exclusion Criteria (Healthy Controls)
- Inability to provide consent.
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Keith Van Haren, MD
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.