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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT group | patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide. |
| |
| RT group | patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractionated stereotactic radiotherapy | Radiation | The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor control rate (LTCR) | the control rate of treated lesions | 3 months after radiation |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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patients with large brain metastases of more than 6 cc.
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| Name | Affiliation | Role |
|---|---|---|
| Jianping Xiao, Dr | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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|
| 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |