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.

BEAD-T1D: Building the Evidence to Address Disparities in Type 1 Diabetes

Youth from low socioeconomic groups are at a systematic disadvantage in the provision of diabetes care, particularly diabetes technology which is associated with improvement in diabetes-specific outcomes. Thus, the type 1 diabetes community urgently need studies to understand and ameliorate the persistent worsening of disparities of diabetes management and outcomes in youth from low socioeconomic backgrounds. This proposed research will (1) improve representation of diverse youth in the literature, (2) address the gap in knowledge of barriers and promoters in publicly insured youth, and (3) identify and address factors of worsening disparity in diabetes technology.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • behavioral: Intervention to increase diabetes technology uptake

Eligibility


Inclusion Criteria:

The investigators will include youth aged 12-21 years in this study. The lower limit of 12
years was selected as this is the age when youth are able to understand and reflect on the
topics discussed in the survey measures and focus groups, such as perceived discrimination.
The upper limit of 21 years was selected as this is the upper limit of public payer
coverage (for example, California Children's Services). This aim focuses specifically on
the family (youth and parent/guardian) factors that determine diabetes technology use and
thus requires that youth are living with their parent/guardian in order to be included in
this study. For youth under 18, the investigators will obtain both parental permission and
youth assent to participate in the study. For those older than 18, the investigators will
obtain consent from the youth alone.

Exclusion Criteria:

   - Diabetes diagnosis in youth other than type 1

   - T1D youth less than the age of 12 or older than 21

   - non-public payer insurance

   - caregivers not living with the youth with type 1 diabetes

Ages Eligible for Study

12 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
Ananta Addala
650-497-9099
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.