Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases (SRTRBM)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Brain Metastases

Treatments: Drug: Temozolomide; Radiation: Fractionated Stereotactic Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02654106

CH-H&N-003

Details and patient eligibility

About

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Refractory Brain Metastases

Experimental group

Description:

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

Treatment:

Radiation: Fractionated Stereotactic Radiotherapy

Drug: Temozolomide