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.

COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial

This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Ruxolitinib
  • drug: Placebo

Eligibility


Inclusion Criteria:

   - Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia
   vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF)
   according to the 2008 World Health Organization criteria

   - Subjects with myelofibrosis requiring therapy must be classified as high risk OR
   intermediate risk level 2 according to the prognostic factors defined by the
   International Working Group

   - Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,
   2 or 3

   - Subjects who have not previously received treatment with a Janus kinase (JAK)
   inhibitor

Exclusion Criteria:

   - Subjects with a life expectancy of less than 6 months

   - Subjects with inadequate bone marrow reserve as demonstrated by specific clinical
   laboratory counts

   - Subjects with inadequate liver or renal function

   - Subjects with clinically significant bacterial, fungal, parasitic or viral infection
   which require therapy

   - Subjects with an active malignancy over the previous 5 years except specific skin
   cancers.

   - Subjects with severe cardiac conditions

   - Subjects who have had splenic irradiation within 12 months

Ages Eligible for Study

18 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
Cancer Clinical Trials Office
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.