Clinical trial NCT03778541: HFSRT With Concurrent TMZ for Large BMs
Official title: Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Brain Metastases
Chemotherapy
Radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2018-12-19
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone group
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: intracranial progression free survival (IPFS) rate
timeFrame: up to 2 years
Secondary outcomes:
measure: local control rate
timeFrame: up to 2 years
measure: Brain metastasis-specific survival (BMSS) rate
timeFrame: up to 2 years
measure: overall survival (OS) rate
timeFrame: up to 2 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria
timeFrame: acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jianping Xiao, Dr
role: PRINCIPAL_INVESTIGATOR
References: