PI/II of Temozolomide & Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
Conditions
Glioblastoma - Cancer of Brain and Nervous System - Glioblastoma Multiforme
Conditions: official terms
Brain Neoplasms - Glioblastoma
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Temozolomide Type: Drug
Name: Stereotactic Radiosurgery Type: Procedure
Overall Status
Recruiting
Summary
The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy with the FDA approved chemotherapy drug temozolomide
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Stanford University School of Medicine
Stanford, California, United States
Status: Recruiting
Contact: Polly Young - 650-497-7499 - polly14@stanford.edu
Start Date
April 2010
Completion Date
July 2016
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page