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.
Evaluation of the Duration of Therapy for Thrombosis in Children
The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage of the trial has consisted of a pilot/feasibility component, which then continues as the definitively-powered trial.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- other: Shortened duration (6 weeks) of anticoagulant therapy
- other: Conventional duration (3 months) of anticoagulant therapy
- other: No Intervention
- other: No Intervention
Eligibility
Inclusion Criteria:
1. Children (birth to <21 years of age) with radiologically-confirmed acute deep venous
thrombosis in the past 30 days
2. In the opinion of the investigator, the venous thrombosis was a provoked (i.e.,
non-spontaneous) event (e.g.: hospitalization; Central venous catheterization;
infection; dehydration; surgery; trauma; immobility; use of estrogen-containing oral
contraceptive pills; flare of autoimmune/rheumatologic condition).
Exclusion Criteria:
1. Prior episode of VTE
2. Malignancy that, in the opinion of the treating oncologist, is not in remission (note:
remission may exist on or off anti-neoplastic therapy)
3. Systemic lupus erythematosus
4. Pulmonary embolism that is not accompanied by DVT or is more proximal than segmental
branches of the pulmonary artery
5. Use of, or intent to use, thrombolytic therapy
6. Chronic anticoagulant at prophylactic dosing is being or will be administered beyond 6
months post VTE diagnosis
7. Moderate/severe anticoagulant deficiency (defined by any one of the following):
1. protein C <20 IU/dL if patient is ≥3 months of age, or protein C below lower
limit of detection if patient is <3 months of age;
2. antithrombin <30 IU/dL if patient is ≥3 months of age, or antithrombin below
lower limit of detection if patient is <3 months of age;
3. protein S (free antigen or activity) <20 IU/dL.
Ages Eligible for Study
N/A - 20 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
Clara Lo
650-723-5535
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.