Skip to main content
OpenTrials
Completed

NCT Number: NCT03338075

FSRT Combined With TMZ for Large BMs: a PSM Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Chemotherapy Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractionated Stereotactic Radiotherapy

Radiation

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

Other names: drugs

Primary outcomes

  1. Local tumor control rate (LTCR)

    Time frame: 3 months after radiation

    the control rate of treated lesions

Secondary outcomes

  1. Intracranial progression- free survival (IPFS)

    Time frame: up to 1 year

    the interval from the beginning of radiation to any intracranial progression

  2. Local recurrence- free survival (LRFS)

    Time frame: up to 1 year

    the time from the beginning of radiation to local faliure.

  3. Overall survival (OS)

    Time frame: up to 3 years

    the time from the beginning of radiation to follow-up or death

  4. Progression- free survival (PFS)

    Time frame: up to 1 year

    the interval from the beginning of HFSRT to any progression of tumor.

  5. Brain metastasis-specific survival (BMSS)

    Time frame: up to 1 year

    the internal from the beginning of radiation to death that caused by brain metastases.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2017
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.