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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Brain Metastases, Adult trials