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.

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma

RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given. The chemotherapy in this study includes the drug methotrexate. This drug was an important part of the two clinical trials which resulted in the best survival results for children less than 3 years of age with medulloblastoma. Most patients treated on this trial will also receive radiation which is carefully targeted to the area of the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in fewer problems with thinking and learning than radiation to the whole brain and spinal cord.

PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system tumors.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Induction Chemotherapy
  • drug: Low-Risk Therapy
  • drug: High-Risk Therapy
  • drug: Intermediate-Risk Therapy

Eligibility


Histologically confirmed newly diagnosed CNS tumors of any of the following :

   - Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic
   medulloblastoma)

   - Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or
   ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)

   - Pineoblastoma

   - Atypical teratoid rhabdoid tumor (ATRT)

   - Choroid plexus carcinoma

   - High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma,
   anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features,
   high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal
   tumor, glioblastoma multiforme), or gliosarcoma,

   - Ependymoma (including all ependymoma histological variants)

   - Age < 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma
   patients ≥ 3 and < 5years old at diagnosis who have non-metastatic disease with no
   more than 1cm2 of residual tumor are also eligible.

      - Meets criteria for 1 of the following risk groups:

   - Low-risk group:

      - Histologically confirmed nodular desmoplastic medulloblastoma, including
      medulloblastoma with extensive nodularity

         - Focal areas of anaplasia or other atypical features suggesting more
         aggressive phenotype in a tumor otherwise considered nodular desmoplastic
         should be treated on the intermediate-risk group, with final risk
         stratification at the discretion of principal investigator and study
         pathologist

      - No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic
      examination of lumbar cerebrospinal fluid (CSF)

         - Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1
         disease when lumbar puncture is medically contraindicated

         - Intermediate-risk group assignment when there is no other evidence of
         metastasis and CSF sampling is not possible

      - Gross total resection, defined as residual tumor or imaging abnormality (not
      definitive for residual tumor) with a size of < 1 cm2 confirmed on postoperative
      CT scan or MRI

      - Brain stem invasion by the tumor in the absence of imaging evidence of residual
      tumor (tumor size < 1 cm2) and otherwise meets criteria for the low-risk group,
      the patient will be classified as low-risk

      - Desmoplastic medulloblastoma patients who are ≥3 -<5 years of age will NOT be
      eligible for the low risk arm of the protocol.

   - Intermediate-risk group:

      - Histologically confirmed nodular desmoplastic medulloblastoma with less than
      gross total resection and no evidence of metastasis

      - Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no
      evidence of CNS metastasis

      - Medulloblastoma patients who are ≥3 and < 5 yrs of age irrespective of histology
      and with no evidence of CNS metastasis

   - High-risk group:

      - Any eligible histologic diagnosis with evidence of CNS metastasis

      - Patients with extraneural metastasis are eligible for treatment on the high-risk
      group

PATIENT CHARACTERISTICS:

   - Lansky performance status ≥ 30 (except for posterior fossa syndrome)

   - WBC > 2,000/mm3

   - Platelets > 50,000/mm3 (without support)

   - Hemoglobin > 8 g/dL (with or without support)

   - ANC > 500/mm3

   - Serum creatinine < 3 times upper limit of normal (ULN)

   - ALT < 5 times ULN

   - Total bilirubin < 3 times ULN

PRIOR CONCURRENT THERAPY:

   - See Disease Characteristics

   - No more than 31 days since prior definitive surgery

   - No prior radiotherapy or chemotherapy other than corticosteroid therapy

Ages Eligible for Study

N/A - 5 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
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.