Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases
- Conditions
- Brain Metastases
- Interventions
- Radiation: Fractionated Stereotactic Radiotherapy
- Registration Number
- NCT02654106
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.
- Detailed Description
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT
- the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc.
- KPS ≥60，or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas.
- Age: 18-75 years old.
- Adequate end-organ function:
WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range
- Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).
- Unable or unwilling to comply with the study protocol.
- The expected survival time is less than 3 months.
- Patients who are anticipated in other clinical trials of brain metastases.
- Patients who has been treated with SRT in other hospitals
- Pregnant patients or female patients whose HCG is positive
- Unsuitable to participate in study, that in the opinion of the treating physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Refractory Brain Metastases Fractionated Stereotactic Radiotherapy Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases Refractory Brain Metastases Temozolomide Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases
- Primary Outcome Measures
Name Time Method intracranial progress free survival rate up to 2 years defined as no progress of the treated lesions and no distant progress in the brain
- Secondary Outcome Measures
Name Time Method progress free survival rate up to 1 year local control rate up to 1 year Overall survival rate up to 3 year disease control rate (DCR) 2-3 months after radiation Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
adverse event from the day of radiation to the end of adjuvant TMZ，up to 6 months assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system
causes of death from the day of radiation to death date, up to 5 years collect the data of causes of death and analyze
Trial Locations
- Locations (1)
Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China