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.
Prevention of Childhood Obesity
This study is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. If the education program can change parental behavior the next study would examine whether this affects children's weight over a longer period of time.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Eligibility
Inclusion Criteria:
For study 1, 60 families (120 parents) with a child between the age of 2-4 years will be
entered to the study. Children of these families will be at risk for overweight because the
family will contain at least one obese parent. For study 2, 100 families (200 parents) will
be entered to the study. Children of these families will be at risk for overweight and have
a reactive temperament. The reason for using this population is that a combination of
parental obesity and a child with a reactive temperament appears to put the child at high
risk for the development of overweight.
Exclusion Criteria:Parental exclusions:
1. Not able to comprehend English well enough to participate in assessments or the
intervention.
2. Serious non-obesity related physical illness, (e.g., cancer), which would preclude
participation in assessment or intervention.
3. Serious current psychiatric disorder, e.g. schizophrenia, uncontrolled bipolar
disorder, mental retardation that would preclude participation in assessment or
intervention.
4. Single parents
Child exclusions:
1. Serious physical illness or related treatments that would affect feeding or weight
including history of feeding aversion, failure to thrive, and use of nasogastric or
gastrostomy feeding.
2. Prematurity below 37-weeks associated with prolonged hospitalization, ongoing need for
nutritional supplementation, or naso-gastric feeding.(parental report)
3. Serious current developmental problems including any that might interfere with
self-feeding or require additional parental feeding support e.g. developmental delay,
autism. (parental report).
Ages Eligible for Study
2 Years - 4 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
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.