This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.
PRIMARY OBJECTIVES: I. To determine the feasibility of using spectroscopic MRI (sMRI) to guide dose-escalated radiation therapy (RT) for newly-diagnosed glioblastoma (GBM)s. II. To determine the safety of using sMRI to guide dose-escalated RT for newly-diagnosed GBMs. SECONDARY OBJECTIVE: I. To determine whether the progression free survival at 1 year with sMRI-guided, dose-escalated RT is improved for newly-diagnosed GBMs. TERTIARY OBJECTIVES: I. To determine whether sMRI-guided, dose-escalated RT increases the overall survival of patients with newly diagnosed GBMs. II. To determine whether sMRI data obtained after initiation of therapy (at 2 weeks after RT/TMZ start and prior to cycle 1 and 5 of adjuvant temozolomide \[TMZ\]) will provide early evidence of GBM progression not seen on standard MRIs. III. To determine whether performance on neurocognitive and quality-of-life (QOL) assessments in newly-diagnosed GBM patients treated with sMRI-guided, dose-escalated RT differ from historical controls. OUTLINE: Patients undergo sMRI-guided radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide orally (PO) daily during radiation therapy for up to 42 days. After completion of study treatment, patients are followed up every 3 months for up to 2 years and then periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Given PO
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform
Feasibility of this approach will be determined by whether treatment volumes based on sMRI can be co-registered with clinical images and transferred into the radiation treatment execution platform in a seamless manner, so that sMRI information can be efficiently applied to the patient treatment.
Time frame: Up to 2 years after completion of therapy
Incidence of Adverse Event Assessed by Common Terminology Criteria for Adverse Events Version 4.0
The safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT.
Time frame: Up to 2 years after completion of therapy
Progression Free Survival (PFS)
Patients were followed at least every 3 months for 2 years from the start of RT.
Time frame: 2 years from the start of RT.
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