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.

Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • other: Sham Injection Procedure
  • drug: QPI-1007 Injection - 1.5 mg
  • drug: QPI-1007 Injection - 3.0 mg

Eligibility


Key Inclusion Criteria:

   - Positive diagnosis of first episode of NAION in the study eye with symptom onset
   within 14 days prior to planned study drug administration/sham procedure

   - Best corrected visual acuity score in the study eye is better than or equal to 15
   letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study
   drug administration/sham procedure.

   - Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus
   examination

Key Exclusion Criteria:

   - Present use or history of any treatment for the current episode of NAION, including
   systemic steroids, brimonidine, or traditional Chinese herbal medicine

   - Prior episode of NAION in the study eye only

   - Present use of drugs known to cause optic nerve or retinal toxicity at Day
   1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin.
   Subjects who need to be prescribed any of these drugs during the course of the study
   will be discontinued from the trial.

   - Any medical condition, concomitant therapy, or previous incisional or laser surgery
   that, in the opinion of the Investigator, would preclude IVT injection in the study
   eye only

   - Clinical evidence of temporal arteritis

Ages Eligible for Study

50 Years - 80 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
Mariana Nunez
650-497-7846
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.

Stanford APBI Trial