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.

Fetal ST Segment and T Wave Analysis in Labor

The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • device: fetal STAN monitor

Eligibility


Inclusion Criteria:

   - Singleton, cephalic pregnancy

   - Gestational age at least 36 weeks, 1 day

   - Cervical dilation of at least 2 cm and no more than 7 cm

   - Ruptured membranes

Exclusion Criteria:

   - Multifetal gestation

   - Planned cesarean delivery

   - Need for immediate delivery

   - Absent variability or sinusoidal pattern at any time, or a Category II fetal heart
   rate pattern with absent variability in the last 20 minutes before randomization

   - Inability to obtain or maintain an adequate signal within 3 trials of electrode
   placements

   - Occurrence of any ST event during attempt to obtain adequate signal

   - Patient pushing in the first stage of labor

   - Known major fetal anomaly or fetal demise

   - Previous uterine surgery

   - Placenta previa on admission

   - Maternal fever greater than or equal to 38 C or 100.4 F

   - Active HSV infection

   - Known HIV or hepatitis infection

   - Other maternal and fetal contraindications for using the STAN monitor

   - Enrollment in another labor study

   - Participation in this trial in a previous pregnancy

   - No certified or authorized provider available

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Dr. Yasser El-Sayed
650 725-8623
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.