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FSRT Combined With TMZ for Large BMs: a PSM Study

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ClinicalTrials.gov Identifier: NCT03338075
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jianping Xiao, 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.

Condition or disease Intervention/treatment
Brain Metastases Radiotherapy Chemotherapy 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.

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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 : January 1, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Group/Cohort 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 Name: 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 Name: drugs




Primary Outcome Measures :
  1. Local tumor control rate (LTCR) [ Time Frame: 3 months after radiation ]
    the control rate of treated lesions


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with large brain metastases of more than 6 cc.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338075


Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Jianping Xiao, Dr Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Jianping Xiao, Dr, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03338075    
Other Study ID Numbers: CH-H&N-004
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes