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Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors
This pilot clinical trial studies the side effects and best dose of radiation therapy in patients with brain tumors that have come back after previous treatment with radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in different ways may kill more tumor cells.
PRIMARY OBJECTIVES: I. To estimate the rate of grade 3 or higher central nervous system (CNS) necrosis 6 months after reirradiation of the brain for recurrent tumor. SECONDARY OBJECTIVES: I. To evaluate acute and late toxicities of reirradiation. II. To evaluate longitudinal changes in symptom burden of patients undergoing reirradiation. III. To use Advanced Brain Tumor Imaging (ABTI) to evaluate changes in the brain after reirradiation, including progression, pseudoprogression, and radionecrosis. IV. To estimate progression-free survival (PFS) and overall survival (OS) following reirradiation. OUTLINE: Patients are assigned to 1 of 2 arms based on age. ARM I (Age 0-18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. ARM II (Age \> 18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month, then every 2 months for 1 year, then every 3 months for 1 year.
Age
All ages
Sex
ALL
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
July 20, 2016
Primary Completion Date
July 31, 2027
Completion Date
July 31, 2027
Last Updated
January 7, 2026
40
ESTIMATED participants
Bevacizumab
BIOLOGICAL
Quality-of-Life Assessment
OTHER
Radiation Therapy
RADIATION
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT06630338
NCT02020720
Data Source & Attribution
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