Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborator: Cancer Foundation, China
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.