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FSRT Combined With TMZ for Large BMs: a PSM Study

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Brain Metastases
Chemotherapy
Radiotherapy

Treatments

Radiation: fractionated stereotactic radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT03338075
CH-H&N-004

Details and patient eligibility

About

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

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

72 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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