NCT03778541

HFSRT With Concurrent TMZ for Large BMs

Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

Detailed description

A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.

Conditions

• Brain Metastases
• Chemotherapy
• Radiotherapy

Interventions

Type	Name	Description
DRUG	Temozolomide	75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.
RADIATION	hypofractionated radiotherapy	the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Timeline

• Start date: 2018-12-03
• Primary completion: 2022-12-03
• Completion: 2022-12-03
• First posted: 2018-12-19
• Last updated: 2019-07-23

Locations

1 site across 1 country: China