Biologically-based Target Volumes to Treat Newly Diagnosed 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03506139|
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Glioblastoma Multiforme||Radiation: External beam radiation therapy||Phase 2|
This study evaluates if increasing radiation dose to at-risk areas impacts overall survival without causing a decrease in quality of life or an increase in radiation side effects.
Standard radiation dose for glioblastoma (GBM) is 60 Gray in 30 fractions, with patients receiving 1 fraction per day, Monday through Friday.
This trial will use a total of 75 Gray in 30 fractions, with participants receiving 1 fraction per day, Monday through Friday. Participants will still receive the standard chemotherapy (temozolomide) at the standard dose (75 mg/m2, once daily, 7 days a week).
This study also uses a different imaging technique to identify the tumor target and the tissues at risk. Normal imaging techniques will be used to define the standard target volume and will receive the standard radiation dose (60 Gray). A special MRI sequence will identify at risk areas based on diffusion and perfusion abnormalities. This area will receive the higher radiation dose (75 Gray).
Participants will also be asked to complete quality of life questionnaires and neurocognitive evaluations at specific time points. This is to identify any side effects from the higher radiation dose. Preliminary work done at University of Michigan suggests a lack of side effects from the higher dose of radiation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Group treated to 75 Gray of radiation to at-risk target|
|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|
|Estimated Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2026|
Experimental: Radiation Therapy
External beam radiation therapy delivered to target volume.
Radiation: External beam radiation therapy
Radiotherapy to 75 Gy Radiation delivered 1 fraction / day, Monday through Friday, for a total of 30 fractions
- Overall survival [ Time Frame: 12 months after completing radiation therapy ]Estimate 12-month overall survival of GBM patients treated with 75 Gray of radiation based on advanced MRI planning, with concurrent temozolomide.
- Progression free survival (PFS) [ Time Frame: Every 2 months, for up to 60 months after completing radiation therapy, until progression or death from any cause ]Estimate progression-free survival (PFS) in GBM patients treated with 75 Gray of radiation based on advanced MRI planning, with concurrent temozolomide.
- Identifying tissue at risk of recurrence [ Time Frame: 12 months after completing radiation therapy ]Assess the ability of pre-treatment and mid-treatment advanced MRI to determine areas at high risk of recurrence
- Distinguish progression from pseudoprogression [ Time Frame: 12 months after completing radiation therapy ]Assess the ability of post-treatment advanced MRI to distinguish progression from pseudoprogression
- Adverse events related to treatment [ Time Frame: Weekly during radiation therapy, every 2 months post-radiation therapy for 7 months, then 13 & 19 months post-radiation ]Provide descriptive data regarding health-related quality of life (QOL), symptoms and neurocognitive function
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): NCT03506139
|Contact: Heather Brown, RN, BAN||(319) email@example.com|
|Contact: Sandy Vollstedt, RN, BSN||(319) firstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Department of Radiation Oncology|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||John M. Buatti, MD||University of Iowa|