Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases (NCT07405047) | Clinical Trial Compass
CompletedNot Applicable
Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases
China33 participantsStarted 2022-09-01
Plain-language summary
This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The primary tumor is proved malignant by pathology;
✓. Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4;
✓. The maximum diameter of each lesion is ≤ 2cm;
✓. Age ≥ 18 years old;
✓. KPS≥ 70;
✓. Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT);
✓. expected survival of more than 6 months;
✓. The functions of vital organs meet the requirements;
Exclusion criteria
✕. Surgical intervention is considered for MDT consultation;
✕. Meningeal metastasis;
✕. The primary tumor is small cell lung cancer;
✕. Follow-up data can't be obtained regularly;
✕. patients are combined with other serious diseases, such as serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 50% indicated by color doppler examination;
What they're measuring
1
local control without symptomatic radiation necrosis rate
Timeframe: 1 year after fractionated stereotactic radiotherapy (FSRT)
Trial details
NCT IDNCT07405047
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences