NCT02698254

Radiation Therapy in Treating Patients With Recurrent Brain Tumors Who Have Undergone Previous Radiation Therapy

Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Brain Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Radiation Therapy	Undergo radiation therapy with conventional fractionation

Timeline

• Start date: 2016-07-20
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2016-03-03
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study