Active — Not RecruitingNot Applicable

Local Treatment Strategies for Brain Metastases of Colorectal Cancer

Belarus, Russia700 participantsStarted 2026-02-01

Plain-language summary

COLBRAIN trial is an international (2 countries) observational, multicenter (15 centers) retrospective cohort study designed to investigate local treatment strategies for brain metastases of colorectal cancer.

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: * Male and female patients aged 18 years or older; * Histologically confirmed epithelial malignancy of the colon or rectum (colorectal adenocarcinoma). Patients with synchronous or metachronous multiple primary tumors within the colon or rectum are eligible; * Radiologically ± histologically confirmed brain metastases, including: * Solid brain parenchymal metastases * Leptomeningeal disease (LMD) * Both solid metastases and LMD Exclusion Criteria: * Synchronous or metachronous multiple primary malignancies (MPM) involving sites other than the colon or rectum * Primary tumor located outside the gastrointestinal tract; * Histologically confirmed non-epithelial gastrointestinal malignancy (e.g., neuroendocrine tumors, sarcoma, gastrointestinal stromal tumor, lymphoma); * Isolated spinal cord involvement without brain parenchymal metastases; * Incomplete medical records precluding assessment of at least one primary endpoint (OS, TTIP, or CNS-PFS). Patients with available data for any primary endpoint are eligible, even if other clinical details are missing. * Prior local treatment for brain metastases at an outside institution with no available records, precluding determination of the first local treatment modality

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

Overall Survival (OS)

Timeframe: From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years (censored)

Time to Intracranial Progression (TTIP)

Timeframe: From date of initial cancer diagnosis until first brain metastasis detection, assessed up to 10 years

Central Nervous System Progression-Free Survival (CNS-PFS)

Timeframe: From the date of first local treatment for BM until subsequent intracranial progression or last imaging follow-up, assessed up to 5 years (censored)

Trial details

NCT IDNCT07448662

SponsorBlokhin's Russian Cancer Research Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-01

View on ClinicalTrials.gov More Colorectal Cancer trials