Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
Trial ID or NCT#
NCT01120639,7,45,17506
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Investigator(s)
Scott G. Soltys, MD
Radiation oncologist
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
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 and Neurological Sciences
Iris C. Gibbs, MD, FACR, FASTRO
Radiation oncologist,
Neuro-oncologist
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Lawrence Recht, MD
Neuro-oncologist
Professor of Neurology and Neurological Sciences (Adult Neurology) and, by courtesy, of Neurosurgery
Contact us to find out if this trial is right for you.
Contact
ccto-office@stanford.edu
650-498-7061
View on ClinicalTrials.gov
