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.
A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort
Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Eligibility
Inclusion Criteria:
- Subject is able and willing to provide informed consent and sign an informed consent
form.
- Subject must sign an authorization for the release of their protected health
information.
- Subject must be ≥50 and ≤85 years of age at the time of enrollment.
- Subject must have hyperglycemia and/or diabetes as one of the following within 90 days
prior to enrollment:
- All glycemic parameters must be measured in an outpatient setting
A. (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR
B. Any (2) PDMs present on consecutive or simultaneous testing:
- Fasting Blood Glucose (FBG) ≥126 mg/dl
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- Random Blood Glucose (RBG) ≥200 mg/dl
- 2h Post Glucose (PG) ≥200mg (11.1 mmol/L) during OGTT (oral glucose tolerance test),
OR
C. Any (1) PDM present followed by an anti-diabetes medication
- Subject must have >1 glycemic parameter measured in the 18 months prior to the
elevated index lab without meeting inclusion criteria A, B, or C.
- Subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24
months post-enrollment.
- Subject or authorized representative must be willing to complete a detailed
questionnaire.
Exclusion Criteria:
- Subject must not have any past history of hyperglycemia and/or diabetes as defined by
inclusion criteria A, B, or C
- Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.
- Subject must not be on active treatment for cancer, carry a current diagnosis of any
cancer, and/or investigated for suspicion of recurrence of past cancer (except
non-melanoma skin cancer or carcinoma in-situ of the cervix).
- Ongoing work up for suspicion of pancreatic cancer is not an exclusion.
- Subject must not have any past history of pancreatic cancer.
- Subject must not be on anti-diabetes medications prior to the elevated index lab.
- Subject must not be on chronic or acute use of steroid medications within 90 days of
the elevated index lab.
- Allowed: Nasal, topical steroids, oral budesonide, ophthalmic
- Subject must not have had a recent (within 1 week of the elevated index lab)
intra-articular steroid injection.
- In the physician's and/or investigator's judgement, subject does not have any
co-morbidities that limit the subject's participation in the study.
Ages Eligible for Study
50 Years - 85 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Walter Park, MD
650-723-4102
I'm interested
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.