FSRT Combined With TMZ for Large BMs: a PSM Study

Study Overview
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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.

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

Conditions
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Brain Metastases, Radiotherapy, Chemotherapy

Intervention / Treatment
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* Radiation: fractionated stereotactic radiotherapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRT group<br>patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide. | Radiation: fractionated stereotactic radiotherapy<br>* The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.<br>* Other names: drugs;|
| RT group<br>patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone. | Radiation: fractionated stereotactic radiotherapy<br>* The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.<br>* Other names: drugs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor control rate (LTCR) | the control rate of treated lesions | 3 months after radiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial progression- free survival (IPFS) | the interval from the beginning of radiation to any intracranial progression | up to 1 year | 
| Local recurrence- free survival (LRFS) | the time from the beginning of radiation to local faliure. | up to 1 year | 
| Overall survival (OS) | the time from the beginning of radiation to follow-up or death | up to 3 years | 
| Progression- free survival (PFS) | the interval from the beginning of HFSRT to any progression of tumor. | up to 1 year | 
| Brain metastasis-specific survival (BMSS) | the internal from the beginning of radiation to death that caused by brain metastases. | up to 1 year |