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.
Sex Differences in Coronary Pathophysiology
This is a research study evaluating possible causes of chest pain (or an anginal equivalent, such as fatigue resulting in a decrease in exercise tolerance, shortness of breath, or back, shoulder, neck, or jaw pain) in people with no evidence of significant coronary artery disease on their coronary angiogram (pictures of the blood vessels in the heart). The purpose of the research study is to determine if there is diffuse atherosclerosis (plaque) not appreciated by angiography, or if the coronary endothelium (lining of the blood vessels in the heart) and/or microcirculation (small vessels in the heart that are not easily seen with an angiogram) are not functioning properly in those who have chest pain (or an anginal equivalent), but normal coronary arteries on angiography. Specifically, we are interested if these findings are more common in women than men.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: 30 cc blood draw
- procedure: Intravascular ultrasound (IVUS)
- procedure: Coronary pressure/flow wire testing
- procedure: Coronary pressure/flow testing: Acetycholine challenge
- procedure: Procedure: Coronary pressure/flow testing: Nitroglycerin challenge
- procedure: Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge
Eligibility
Inclusion Criteria:
1. Patient referred for elective coronary angiography because of a reasonable clinical
suspicion of coronary ischemia.
2. Presence of angina or an anginal equivalent (including chest, back, shoulder, arm,
neck, jaw discomfort, or shortness of breath brought on by physical exertion,
emotional stress, or certain times of day/month).
Exclusion Criteria:1) Asymptomatic (such as a pre-op cath)
2) Status-post heart transplant
3) Status-post coronary artery bypass grafting
4) Age <18
5) Renal insufficiency (creatinine >1.5)
6) Presence of an acute coronary syndrome (STEMI or NSTEMI), Tako-tsubo, an abnormal
ejection fraction (EF<55%), cardiogenic shock, or recent VT/VF
7) Presence of another likely explanation of chest pain, such as pulmonary hypertension or
aortic stenosis
8) History of adverse reaction to any of the medications being used (acetylcholine,
nitroglycerin, adenosine, or heparin)
9) Currently taking vasoactive medication (such as nitroglycerin)
10) Inability to provide an informed consent, including an inability to speak, read, or
understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese
11) A hearing impairment that won't allow for a typical verbal conversation or a visual
impairment that won't allow for reading of the written consent
12) Participation in another study (with the exception of the Stanford Gene-PAD study)
13) A potentially vulnerable subject (including minors, pregnant women, economically and
educationally disadvantaged, decisionally impaired, and homeless people)
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Homa Tavana
650-721-5540
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.