PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study
To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of
patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study
whether PPX/RT improves overall survival as compared to temozolomide /RT for patients with
GBM without MGMT methylation to facilitate planning a phase III study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
evaluate the toxicities of PPX/RT at years 1 and 2 of the trial
Patients will be evaluated throughout their treatment however a cumulative evaluation will be conducted at years 1 and 2 of the trial
At years 1 and 2
Yes
Howard Safran, MD
Principal Investigator
BrUOG
United States: Food and Drug Administration
BrUOG 244
NCT01402063
September 2011
December 2013
Name | Location |
---|---|
Rhode Island Hospital | Providence, Rhode Island 02903 |
Maine Medical Center | Portland, Maine 04102 |
University of Washington | Seattle, Washington 98195 |
UCSD Cancer Center | La Jolla, California 92093-0064 |
UMASS Medical Center Cancer Center | Worcester, Massachusetts 01605 |
PSU | Hershey, Pennsylvania 17033 |