Hypofractionated Intensity-Modulated Radiation Therapy With Temozolomide and Bevacizumab for Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT01209442|
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: Bevacizumab Drug: Temozolomide Radiation: RT (Radiation Therapy)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) and Bevacizumab for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)|
|Actual Study Start Date :||September 16, 2010|
|Actual Primary Completion Date :||September 7, 2014|
|Actual Study Completion Date :||February 3, 2017|
Experimental: RT with Temozolomide and Bevacizumab
Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily TMZ at 75 mg/m2 qd concurrent with IMRT (including weekends and holidays). Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Day 1 and the 1st Fx of IMRT must start on the same day. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab therapy, patients will have a brain MRI and if there is no evidence of disease progression, patients will receive 6 cycles of Bevacizumab and TMZ. Beginning a minimum of 28 days after the last radiation treatment the bevacizumab will be dosed at 10 mg/kg on day 1 and day 15 of each cycle. TMZ will be given at 150-200 mg/m2 qd on days 1-5 of each cycle. Each cycle is 28 days.
Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, patients will receive 6 cycles of Bevacizumab.
Other Name: Avastin
Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily temozolomide at 75 mg/m2 qd concurrent with IMRT. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, temozolomide will be given at 150-200 mg/m2 qd on days 1-5 of each cycle.
Other Name: Temodar
Radiation: RT (Radiation Therapy)
Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx)
- 6-month progression-free survival [ Time Frame: 6 months ]To use 6-month progression-free survival to assess the efficacy of the combination of hypofractionated IMRT delivering 60 Gy over 2 weeks with concurrent bevacizumab and temozolomide followed by 6 cycles of adjuvant bevacizumab and temozolomide.
- Overall survival, measured from the day of initial diagnosis (biopsy or surgery) to the time of death from any cause. [ Time Frame: follow up for life ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209442
|United States, Colorado|
|University of Colorado Denver, University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Douglas Ney, M.D||University of Colorado, Denver|