Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

Not Recruiting

Trial ID: NCT01120639,7,45,17506

Purpose

The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

Official Title

A Phase 1-2 Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme

Stanford Investigator(s)

Scott G. Soltys, MD
Scott G. Soltys, MD

Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Steven D. Chang, MD
Steven D. Chang, MD

Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology

Iris C. Gibbs, MD, FACR, FASTRO
Iris C. Gibbs, MD, FACR, FASTRO

Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

Lawrence Recht, MD
Lawrence Recht, MD

Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Eligibility


Inclusion Criteria:

   - Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must
   be made by surgical biopsy or excision

   - The tumor must be supratentorial in location

   - The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume

   - Age ≥ 18 years

   - Life expectancy of at least 12 weeks

   - Patient must have adequate organ function to tolerate temozolomide (details in the
   protocol)

Exclusion Criteria:

   - Patients who have previously been treated with brain irradiation to the region that
   would result in overlap of the radiation fields

   - Tumor foci detected below the tentorium

   - Multifocal disease or leptomeningeal spread

   - Prior allergic reaction to the study drugs involved in this protocol

   - Patients with pacemaker will be allowed to undergo CT instead of MRI

   - Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded

Intervention(s):

drug: Temozolomide

procedure: Stereotactic Radiosurgery (SRS)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061

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