HFSRT With Concurrent TMZ for Large BMs

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Brain Metastases; Chemotherapy; Radiotherapy

Treatments: Radiation: hypofractionated radiotherapy; Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT03778541

LBM-RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

CRT group

Experimental group

Description:

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.

Treatment:

Drug: Temozolomide

Radiation: hypofractionated radiotherapy

RT group

Active Comparator group

Description:

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.

Treatment:

Radiation: hypofractionated radiotherapy