Brain Metastases, Chemotherapy, Radiotherapy
Conditions
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.
Interventions
DRUGTemozolomide
75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.
RADIATIONhypofractionated radiotherapy
the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJianping Xiao, Dr
Outcome results
None listed