FSRT Combined With TMZ for Large BMs: a PSM Study

Completed

• Conditions: Chemotherapy; Brain Metastases; Radiotherapy
• Interventions: Radiation: fractionated stereotactic radiotherapy

• Registration Number: NCT03338075
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

Detailed Description

A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Study First Posted: 2017-11-09
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• (1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (MRI) ; (2) age 18 years or older (3) KPS ≥60, or KPS ≥50 but symptomatically caused by BMs; (4) the large lesions haven't treated with surgery or SRT.

Exclusion Criteria

• (1) KPS <60 but not caused by BMs; (2) the large lesions have been treated with surgery or SRT.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RT group	fractionated stereotactic radiotherapy	patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.
CRT group	fractionated stereotactic radiotherapy	patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.

Primary Outcome Measures

Name	Time	Method
Local tumor control rate (LTCR)	3 months after radiation	the control rate of treated lesions

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 3 years	the time from the beginning of radiation to follow-up or death
Intracranial progression- free survival (IPFS)	up to 1 year	the interval from the beginning of radiation to any intracranial progression
Local recurrence- free survival (LRFS)	up to 1 year	the time from the beginning of radiation to local faliure.
Progression- free survival (PFS)	up to 1 year	the interval from the beginning of HFSRT to any progression of tumor.
Brain metastasis-specific survival (BMSS)	up to 1 year	the internal from the beginning of radiation to death that caused by brain metastases.