A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02805179|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Radiation: High Dose Radiation Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-Based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma|
|Actual Study Start Date :||September 22, 2016|
|Actual Primary Completion Date :||February 6, 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: High Dose Chemoradiation
Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide.
Radiation: High Dose Radiation
Radiation will be delivered once daily for a total of 30 fractions, five days per week.
Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
- Overall survival at 12 months [ Time Frame: 12 months after completion of chemoradiation ]Number of patients alive at 12 months after completion of chemoradiation
- Number of patients alive without progression at 12 months [ Time Frame: 12 months after completion of chemoradiation ]Time from study enrollment until disease progression per standard response assessment in neuro-oncology (RANO) criteria or death from any cause, up to 12 months after completion of chemoradiation.
- Average change in tumor volume from baseline to mid-treatment (Week 4) [ Time Frame: Baseline to Week 4 ]Tumor volume will be measured by diffusion MRI before treatment start and at mid-treatment. The difference in tumor volume (Week-4 volume minus Week-0 volume) for each patient will be determined and then averaged.
- Progression Free Survival [ Time Frame: Up to 2 years after completion of chemoradiation ]Number of patients alive without progression at 2 years after completion of chemoradiation.
- Overall Survival at 2 years [ Time Frame: At 2 years after completion of chemoradiation ]Number of patients alive at 2 years after completion of chemoradiation.
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): NCT02805179
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Michelle Kim, M.D.||University of Michigan Rogel Cancer Center|