Brain Metastases, Chemotherapy, Radiotherapy
Conditions
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.
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.
Interventions
The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
Sponsors
Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local tumor control rate (LTCR) | 3 months after radiation | the control rate of treated lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence- free survival (LRFS) | up to 1 year | the time from the beginning of radiation to local faliure. |
| Intracranial progression- free survival (IPFS) | up to 1 year | the interval from the beginning of radiation to any intracranial progression |
| Overall survival (OS) | up to 3 years | the time from the beginning of radiation to follow-up or death |
| Progression- free survival (PFS) | up to 1 year | the interval from the beginning of HFSRT to any progression of tumor. |
| Brain metastasis-specific survival (BMSS) | up to 1 year | the internal from the beginning of radiation to death that caused by brain metastases. |
Outcome results
None listed