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FSRT Combined With TMZ for Large BMs: a PSM Study

NCT ID: NCT03338075

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-08-01

Brief Summary

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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

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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.

Conditions

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Brain Metastases Radiotherapy Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CRT group

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.

fractionated stereotactic radiotherapy

Intervention Type RADIATION

The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

RT group

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.

fractionated stereotactic radiotherapy

Intervention Type RADIATION

The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Interventions

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fractionated stereotactic radiotherapy

The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Intervention Type RADIATION

Other Intervention Names

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drugs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jianping Xiao

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianping Xiao, Dr

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other Identifiers

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CH-H&N-004

Identifier Type: -

Identifier Source: org_study_id