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FSRT Combined With TMZ for Large BMs: a PSM Study

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03338075
Collaborator
(none)
72
Enrollment
19
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: fractionated stereotactic radiotherapy

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 Design

Study Type:
Observational
Actual Enrollment :
72 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
CRT group

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

Radiation: fractionated stereotactic radiotherapy
The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
Other Names:
  • drugs

    		•
    RT group

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

    Radiation: fractionated stereotactic radiotherapy
    The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
    Other Names:
  • drugs

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Local tumor control rate (LTCR) [3 months after radiation]

      the control rate of treated lesions

    Secondary Outcome Measures

    1. Intracranial progression- free survival (IPFS) [up to 1 year]

      the interval from the beginning of radiation to any intracranial progression

    2. Local recurrence- free survival (LRFS) [up to 1 year]

      the time from the beginning of radiation to local faliure.

    3. Overall survival (OS) [up to 3 years]

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

    4. Progression- free survival (PFS) [up to 1 year]

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

    5. Brain metastasis-specific survival (BMSS) [up to 1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    • Principal Investigator: Jianping Xiao, Dr, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianping Xiao, Dr, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03338075
    Other Study ID Numbers:
    • CH-H&N-004
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    Nov 9, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Brain Neoplasms

    Study Results

    No Results Posted as of Nov 9, 2017