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.

Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Cetuximab-IRDye800
  • drug: Cetuximab

Eligibility


INCLUSION CRITERIA

   - Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma

   - Planned standard of care surgery with curative intent for pancreatic adenocarcinoma

   - ≥ 19 years of age

   - Life expectancy of more than 12 weeks

   - EITHER

      - Karnofsky performance status of at least 70%, OR

      - Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1

   - Hemoglobin ≥ 9 gm/dL

   - Platelet count ≥ 100,000/mm^3

   - Magnesium > the lower limit of normal (LLN) per institution normal lab values

   - Potassium > LLN

   - Calcium > LLN

   - Thyroid-stimulating hormone (TSH) < 13 micro International units/mL

EXCLUSION CRITERIA

   - Received an investigational drug within 30 days prior to first dose of cetuximab
   IRDye800

   - Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive
   heart failure (CHF); or unstable angina within 6 months prior to enrollment

   - History of infusion reactions to cetuximab or other monoclonal antibody therapies

   - Pregnant or breastfeeding

   - Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than
   440 ms in males or greater than 450 ms in females)

   - Lab values that in the opinion of the primary surgeon would prevent surgical resection

   - Patients receiving class IA (quinidine, procainamide) or class III (dofetilide,
   amiodarone, sotalol) antiarrhythmic agents

Ages Eligible for Study

19 Years - N/A

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
CCTO
650-498-7061
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.