Tomotherapy for Refractory Brain Metastases (TRBM)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Brain Metastases

Treatments: Radiation: tomotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03027544

NCC2014 YZ-14

Details and patient eligibility

About

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.

Full description

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy 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: 150 estimated 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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150 participants in 1 patient group

experimental arm

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. Intervention：tomotherapy

Treatment:

Radiation: tomotherapy