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.

Aromatherapy for HSCT Distress

The purpose of this research is to evaluate aromatherapy inhaler use and how it may impact cancer distress and coping by patients in the first few days after hematopoietic stem cell transplant (HSCT).

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • other: Aromatherapy Inhaler

Eligibility


Inclusion Criteria:

   - Autologous and Allogeneic patients admitted to E1 for planned HSCT

   - Patients with hematologic malignancies requiring HSCT

   - No allergies to lavender or peppermint essential oils

   - Must have received chemotherapy during preparative regimen (single or multi-agent
   regimen)

   - Adult patient over 18 years of age

   - Able to speak, read, and comprehend English

   - Willing and capable of providing informed consent

Exclusion Criteria:

   - Patients admitted for Chimeric Antigen Receptor T cell (CART) infusion

   - Patients receiving a transplant for a germ cell tumor diagnosis

   - Unexpected/unplanned admission (e.g., neutropenic fever, confusion, clinical
   deterioration)

   - Immune effector cell-associated neurotoxicity syndrome (ICANS) grade 1 through 4

   - History of scleroderma

   - History of atrial fibrillation

   - Known history of G6PD deficiency

   - Allergic to lavender or peppermint essential oils

   - Pediatric patient 18 years of age or less

   - Unable to speak, read, and comprehend English

   - Unwilling or incapable of providing informed consent

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
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.