HFSRT With Concurrent TMZ for Large BMs
- Conditions
- Brain MetastasesRadiotherapyChemotherapy
- Interventions
- Radiation: hypofractionated radiotherapy
- Registration Number
- NCT03778541
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 224
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRT group hypofractionated radiotherapy patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide. RT group hypofractionated radiotherapy patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone. CRT group Temozolomide patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
- Primary Outcome Measures
Name Time Method intracranial progression free survival (IPFS) rate up to 2 years IPFS was defined as the interval from the beginning of radiation to any intracranial progression
- Secondary Outcome Measures
Name Time Method local control rate up to 2 years the control rate of treated lesions
Brain metastasis-specific survival (BMSS) rate up to 2 years BMSS was defined as the internal from the beginning of RT to death caused by BM
overall survival (OS) rate up to 2 years OS was defined as the internal from the beginning of RT to death caused by any reason
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT the toxicities caused by RT and (or) Chemotherapy
Trial Locations
- Locations (1)
Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China