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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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


Scott G. Soltys, MD
Scott G. Soltys, MD
Radiation oncologist
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
Steven D. Chang, MD
Steven D. Chang, MD
Neurosurgeon, Aneurysm neurosurgeon, Cerebrovascular neurosurgeon, Pituitary tumors neurosurgeon, Stereotactic neurosurgeon
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
Radiation oncologist, Neuro-oncologist
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

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