NCT07448662|Active Not RecruitingDMC
Local Treatment Strategies for Brain Metastases of Colorectal Cancer
COLBRAIN
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COLBRAIN
Sponsor study identifier
observational
700
2 countries
15
Study Start
February 1, 2026
Actual (reported)Primary Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2026
Actual (reported)February 19, 2026
Actual (reported)March 4, 2026
Actual (reported)October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall Survival (OS)
Time from the date of brain metastasis diagnosis to the date of death from any cause or last follow-up (censored)
From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years (censored)
Time to Intracranial Progression (TTIP)
Time from the date of initial colorectal cancer diagnosis to the date of first brain metastasis detection. Based on this interval, patients will be categorized as synchronous (≤ 60 days from primary diagnosis) or metachronous (\> 60 days).
From date of initial cancer diagnosis until first brain metastasis detection, assessed up to 10 years
Central Nervous System Progression-Free Survival (CNS-PFS)
Time from the date of first local treatment for brain metastases to the date of subsequent intracranial progression or last instrumental follow-up (censored). Intracranial progression includes: continued growth of treated lesion (≤ 6 months after treatment), local recurrence of treated lesion (\> 6 months after treatment), or development of new intracranial lesions.
Adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases
Patients in this cohort underwent neurosurgical resection as the primary local treatment for brain metastases. Surgical approaches include: * En-bloc resection (EBR): gross-total removal of the tumor as a single, intact specimen with no residual disease on postoperative MRI; * Total piecemeal resection (TPR): gross-total removal of the tumor in multiple fragments with no residual disease on postoperative MRI * Subtotal (SPR) or partial (PPR) piecemeal resection: incomplete removal of the tumor, with macroscopic residual disease on postoperative MRI. This includes: * Subtotal resection: 75-90% of tumor volume removed * Partial resection: 30-75% of tumor volume removed * Extent of resection unknown: surgical resection performed, but the precise extent could not be determined from available records
The study population consists of adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases. Patients with synchronous or metachronous multiple primary tumors confined to the colon or rectum are eligible. Patients referred after initial local treatment for brain metastases are included provided that complete documentation of the first treatment modality is available.
Gomel Regional Clinical Oncology Dispensary (OKOD)
Homyel, 246012, Belarus
Kaliningrad Regional Clinical Oncology Center
Kaliningrad, 236016, Russia
Moscow Regional Oncology Hospital No. 62
Krasnogorsk, 143442, Russia
A.S. Loginov Moscow Clinical Scientific Center
Moscow, 111123, Russia
S.S. Yudin City Clinical Hospital, Oncology Center No. 1
Moscow, 115446, Russia
Blokhin's Russian Cancer Research Center
Moscow, 115478, Russia
OncoStop CyberKnife Center
Moscow, 115478, Russia
33P Molecular-genetic concordance of the primary tumor and brain metastases of colorectal cancer (GENCONCOR-1). Khalafyan, D. et al. ESMO Open, Volume 9, 103779
484P. Molecular-genetic concordance of the primary tumor and brain metastases of colorectal cancer (GENCONCOR-1): second interim analysis. Halafyan, D. et al. Annals of Oncology, Volume 35, S1582
David Khalafyan, MD
Blokhin's Russian Cancer Research Center
Alexey Tryakin, MD, professor
Blokhin's Russian Cancer Research Center
Ali Bekyashev, MD, professor
Blokhin's Russian Cancer Research Center
700 participants (actual enrollment reported by the registry).
First Submitted
February 19, 2026
First Posted
March 4, 2026
Study Start
February 1, 2026
Actual (reported)Study on the Prediction of Regional Lymph Node Metastasis in Colorectal Cancer by Spectral CT Combined With MSI
From the date of first local treatment for BM until subsequent intracranial progression or last imaging follow-up, assessed up to 5 years (censored)
Overall Survival from Initial Diagnosis
From date of initial cancer diagnosis until death or last contact, assessed up to 5 years
Cancer-Specific Survival
From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years
Cumulative Incidence of Death from Intracranial Progression
From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years
Cumulative Incidence of Death from Extracranial Progression
From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years
Cumulative Incidence of Death from Non-cancer Causes
From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years
Patients in this cohort received radiotherapy as the primary local treatment modality for brain metastases. Treatment modalities include: * Stereotactic radiosurgery (SRS): single-fraction, high-precision radiation with a prescribed dose \> 12 Gy; * Staged stereotactic radiosurgery (stSRS): radiosurgery delivered in 2-3 stages, typically 2-4 weeks apart, allowing for tumor volume reduction between stages; * Stereotactic radiotherapy (hypofractionated) (SRT): stereotactic radiation delivered in multiple fractions, including: * 3 fractions (single dose 7-9 Gy, total dose 21-27 Gy); * 5 fractions (single dose 6-7 Gy, total dose 30-35 Gy); * 7 fractions (single dose 5 Gy, total dose 35 Gy). * Whole-brain radiotherapy (WBRT): conventional fractionated radiation to the entire brain.
Patients in this cohort received a combination of local treatment approaches. This includes: * NRS with postoperative WBRT; * NRS with postoperative SRT/SRS; * Preoperative SRS followed by NRS; * Combination radiotherapy (SRS and WBRT, SRT and WBRT, SRS and SRT)
Patients in this cohort did not receive any local treatment for their brain metastases. This may include patients receiving best supportive care (BSC) (typically includes the administration of corticosteroids for symptomatic control of peritumoral edema and neurological symptoms) or systemic therapy alone. Reasons for not receiving local treatment may include poor performance status, extensive intracranial disease, or patient preference.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Moscow Multidisciplinary Clinical Center "Kommunarka"
Moscow, 117303, Russia
Gamma Knife Center Moscow
Moscow, 125047, Russia
N.N. Burdenko National Medical Research Center of Neurosurgery
Moscow, 125047, Russia
P.A. Hertsen Moscow Oncology Research Institute
Moscow, 125284, Russia
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090, Russia
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758, Russia
Federal Center of Neurosurgery
Tyumen, 625062, Russia
Republican Clinical Oncology Dispensary (RCOD)
Ufa, 450054, Russia
Primary Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 4, 2026
Record last verified: 2026-02
De-identified individual participant data collected for this study, including data dictionaries, will be available upon reasonable request from the corresponding author beginning 6 months after publication and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal for use approved by an independent review committee. Proposals should be directed to the corresponding author.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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