HFSRT With Concurrent TMZ for Large BMs

• Status: Recruiting
• Trial end date: 2022-12-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;

• the number of BMs ≤ 3

• the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;

• Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;

• Age: 18-75 years old;

• Adequate function of major organs, and blood test reached the following level:

WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.

Exclusion Criteria:

• patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);

• unable or unwilling to comply with the study protocol;

• patient whose survival expectancy was less than 3 months;

• the large BM locates in brainstem;

• patient who anticipated in other clinical trials of brain metastases;

• the large lesions have been treated with SRT in other hospitals;

• pregnant patients or female patients whose HCG is positive.