A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02805179|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : January 9, 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|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
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.
- Number of patients alive at 12 months [ Time Frame: 12 months ]
- Number of patients alive without progression at 12 months [ Time Frame: 12 months ]
- Radiographic response rate [ Time Frame: 12 months ]
- Calculated difference between tumor volume measured by 11C Methionine Positron Emission Tomography (MET-PET) and diffusion MRI [ Time Frame: Baseline, Day 0 ]The tumor volume by PET (Positron Emission Tomography) and tumor volume by Diffusion MRI will be determined. The difference (result of subtraction of the smaller measurement from the larger measurement) will be reported and averaged for the patients.
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|