Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Brain Metastases

Treatments

Radiation: tomotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04178330
NCC2014 YZ-14-01

Details and patient eligibility

About

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

Full 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).

Enrollment

82 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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;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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

82 participants in 1 patient group

Group A
Experimental group
Description:
patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT).
Treatment:
Radiation: tomotherapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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