FSRT Combined With TMZ for Large BMs: a PSM Study

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338075
• Other study ID #: CH-H&N-004
• Status: Completed
• Phase: N/A
• First received: November 7, 2017
• Last updated: November 7, 2017
• Start date: January 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: November 2017
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Chemotherapy
• Neoplasm Metastasis
• Radiotherapy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor control rate (LTCR)	the control rate of treated lesions	3 months after radiation
Secondary	Intracranial progression- free survival (IPFS)	the interval from the beginning of radiation to any intracranial progression	up to 1 year
Secondary	Local recurrence- free survival (LRFS)	the time from the beginning of radiation to local faliure.	up to 1 year
Secondary	Overall survival (OS)	the time from the beginning of radiation to follow-up or death	up to 3 years
Secondary	Progression- free survival (PFS)	the interval from the beginning of HFSRT to any progression of tumor.	up to 1 year
Secondary	Brain metastasis-specific survival (BMSS)	the internal from the beginning of radiation to death that caused by brain metastases.	up to 1 year