The Radiation Therapy Oncology Group (RTOG) has opened a new phase III trial for patients with newly diagnosed glioblastoma (GBM) to determine if the addition of bevacizumab improves patient outcomes, compared with the current standard-of-care therapy--concurrent chemoradiation and adjuvant temozolomide.
Mark R. Gilbert, MD, the study's principal investigator and professor of neuro-oncology at the University of Texas M.D. Anderson Cancer Center, said the goal of the trial was designed as a natural progression to evaluate the benefits of the combination therapy in newly diagnosed GBM, is to demonstrate improvements in progression-free and overall survival in all GBM patients being treated with the combination therapy versus temozolomide/radiation therapy alone.
The trial will enroll 720 patients with histopathologically confirmed glioblastoma from RTOG member institutions in North America and internationally. Members of the North Central Cancer Treatment Group and the Eastern Cooperative Oncology Group will also participate in the study, according to RTOG.
All patients will receive standard therapy of radiation and daily temozolomide for three weeks. Patients will then be stratified by MGMT methylation status and molecular profile to receive standard therapy plus bevacizumab or a continuation of standard therapy plus placebo.
RTOG investigators will examine progression-free and overall survival rates, tumor molecular profiles for prognostic factors, neurocognitive function, health-related quality of life, patient-reported outcomes, treatment side-effects and the interactions between these factors.
The trial protocol is available at http://www.rtog.org/members/protocols/0825/0825.pdf.