RTOG 0825: Glioblastoma
RTOG 0825: PHASE III DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF CONVENTIONAL CONCURRENT CHEMORADIATION AND ADJUVANT TEMOZOLOMIDE PLUS BEVACIZUMAB VERSUS CONVENTIONAL CONCURRENT CHEMORADIATION AND ADJUVANT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA
Approval Date: 9/21/2009
Principal Investigator: Peter Chen, MD
The purpose of this study is to determine whether the addition of bevacizumab to the standard chemoradiation will further improve the outcome. This study will find out what effects, good and/or bad, this change in treatment has on you and on your tumor compared with standard treatment. Bevacizumab is an antiangiogenic agent, which means that it can interrupt the body’s ability to grow new blood vessels, causing tumors to shrink. There is also information that demonstrates that bevacizumab may eliminate poorly formed blood vessels in tumors, resulting in improved blood flow. This improved blood flow may result in better delivery of chemotherapy agents. There are preliminary studies that suggest that combining chemotherapy drugs with bevacizumab may be better than either the chemotherapy agent alone or bevacizumab alone for treating some types of tumors. The study doctors want to see whether this will be true for glioblastoma.
Each study has its own guidelines for who can participate, called ‘eligibility criteria.’ Below is a partial list of criteria for acceptance into the research study. Only the study doctor can make the determination that you meet all eligibility criteria.
- Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV)
- Recurrent or multifocal malignant gliomas are not eligible
- No previous chemotherapy for head and neck cancer
- No previous temozolomide, bevacizumab, or Gliadel wafers
- More than 4 weeks since surgery or open biopsy
Status of Clinical Trial:
open and enrolling