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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
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Heather Wakelee
Winston Chen and Phyllis Huang Professor
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
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
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