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.
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: omalizumab
- dietary supplement: Food proteins
Eligibility
Inclusion Criteria:
- Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic
subjects between the ages of 4 to 55 years old.
- Sensitivity to food allergen will be documented by a positive skin prick test result
or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.
Exclusion Criteria:
- No absolute contraindications are known. However, the risk of serious systemic
anaphylactic reactions to food allergens suggests a number of preexisting conditions
that should be considered relative contraindications. Among those conditions are acute
infections, autoimmune disease, severe cardiac disease, and treatment with
beta-adrenergic antagonistic drugs (beta-blockers).
- Subjects with a total IgE at screening of >2,000 kU/L
- Previous reaction to omalizumab
- Subjects having a history of severe anaphylaxis to food allergens that will be
desensitized in this study requiring intubation or admission to an ICU, frequent
allergic or non-allergic urticaria, or history consistent with poorly controlled
persistent asthma.
Ages Eligible for Study
4 Years - 55 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
Tina Dominguez, PA
safar_inquiry@stanford.edu
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.