An observational study in Brain Metastases, Radiotherapy and Chemotherapy, sponsored by Chinese Academy of Medical Sciences. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-09.
Sponsored by Chinese Academy of Medical Sciences · Observational
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.
patients with large brain metastases of more than 6 cc.
Exclusion Criteria:
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
Radiation: fractionated stereotactic radiotherapy
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.
Also known as: drugs
Local tumor control rate (LTCR)
the control rate of treated lesions
Time frame: 3 months after radiation
Intracranial progression- free survival (IPFS)
the interval from the beginning of radiation to any intracranial progression
Time frame: up to 1 year
Local recurrence- free survival (LRFS)
the time from the beginning of radiation to local faliure.
Time frame: up to 1 year
Overall survival (OS)
the time from the beginning of radiation to follow-up or death
Time frame: up to 3 years
Progression- free survival (PFS)
the interval from the beginning of HFSRT to any progression of tumor.
Time frame: up to 1 year
Brain metastasis-specific survival (BMSS)
the internal from the beginning of radiation to death that caused by brain metastases.
Time frame: up to 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese Academy of Medical Sciences