Radiation Boost for Newly Diagnosed Glioblastoma Multiforme
Procedure: External Beam Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme|
- Treatment-related toxicity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 6 month, 1 year and overall survival. [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Tumor progression. [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Progression-free survival. [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Quality of life. [ Time Frame: End of study ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
The study design is multi-centered and non-randomized. Patients with newly diagnosed GBM undergoing initial surgical resection will be candidates for this study. Eligible patients will undergo surgical resection within 30 days of diagnosis.
Newly diagnosed patients with presumed diagnosis of GBM will undergo surgery for maximal resection. After frozen section diagnosis of GBM is confirmed, the GliaSite® will be placed into the tumor cavity.
After the patient recovers from surgery, radiation therapy (60 Gy to 1 cm) is delivered via the GliaSite®. Radiation therapy with the GliaSite® will be initiated within 21 days after surgery. Concomitant temozolomide (75 mg/m2/d) is started 2 days prior to radiation therapy with the GliaSite® and continued for a total of 7 days.
Within 21 days following radiation therapy with the GliaSite®, external beam radiation therapy (60 Gy in 30 fractions) will be initiated. Concomitant temozolomide (75 mg/m2/d) will start on day 1 of external beam radiation therapy and continue through the external beam radiation therapy interval, ending with the last day of radiation.
Four weeks (+/- 2 days) after completion of external beam radiation therapy, temozolomide (150 mg/m2/d) for 5 days every 28 days will be initiated for one cycle.
At the start of cycle 2, the dose will be escalated to 200 mg/m2/d, if the CTC non-hematological toxicity for cycle 1 is Grade < 2 (except for alopecia, nausea and vomiting).
This will continue for up to a total of 12 cycles, unless disease progression or severe myelosuppression is noted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376103
|United States, Tennessee|
|Methodist University Hospital|
|Memphis, Tennessee, United States, 38104|
|Principal Investigator:||Allen K Sills, MD||Methodist University Hospital|