Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

Not Applicable

Completed

• Conditions: Brain Metastases
• Interventions: Radiation: tomotherapy

• Registration Number: NCT04178330
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.

Detailed Description

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2017-06-13
• Study Completion: 2017-06-13
• Status Verified: 2019-11
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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;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 organ function:WBC≥4.0x109/L, Neu ≥ 1.5x109/L, Hemoglobin ≥ 110 g/L, Platelets ≥100 x109/L, Totalbilirubin ≤ 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 WBRT. 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
Group A	tomotherapy	patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT).

Primary Outcome Measures

Name	Time	Method
Disease control rate(DCR)	2-3 month after radiation	Using RTOG9508 criteria, tumor control is defined as CR+PR+SD

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years	the time from radiation to death
intracranial progress free survival rate	up to 1 year	the time from radiation to local recurrence and/or new brain metastases
progress free survival	up to 1 year	the time from radiation to any progression
local control rate	up to 1 year	the time from radiation to the treated brain metastases recurrence
adverse event	from the day of radiation, up to 3 years	acute and late toxicities

Trial Locations

Locations (1)

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