Tomotherapy for Refractory Brain Metastases

Not Applicable

• Conditions: Brain Metastases
• Interventions: Radiation: tomotherapy

• Registration Number: NCT03027544
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-09-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	tomotherapy	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

Primary Outcome Measures

Name	Time	Method
Objective response rate	2-3 months after radiation	Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	up to 3 years
progress free survival rate	up to 1 year
local control rate	up to 1 year
intracranial progress free survival rate	up to 1 year
adverse event	from the day of radiation, up to 6 months
cause of death	from the day of radiation to death date, up to 5 years

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China