Local Treatment Strategies for Brain Metastases of Colorectal Cancer

NCT07448662 | Active Not Recruiting DMC

• 1 other identifier: 1155221705
• Study Type: observational
• Target: 700
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Colorectal Cancer; Brain Metastases, Adult

Keywords

Colorectal cancer; Colon cancer; Rectal cancer; Brain metastases; Brain metastasis; Central nervous system metastases; CNS; Neurosurgery; En-bloc resection; Piecemeal resection; Stereotactic radiosurgery; SRS; Staged stereotactic radiosurgery; Stereotactic radiotherapy; SRT; Hypofractionated radiotherapy; Whole-brain radiotherapy; WBRT; Radiotherapy; Local treatment; Cohort study; Observational study; Retrospective study; Real-world data; RWD; Overall survival; OS; Time to intracranial progression; TTIP; CNS-PFS; GPA; RANO-BM

Outcome Measures

Primary Outcomes (3)

• 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.

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

Secondary Outcomes (6)

• 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

Study Arms (1)

Eligible Patients

Adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases

Procedure: Neurosurgical Resection (NRS): En-bloc (EBR), Total piecemeal (TPR), Subtotal (SPR) or Partial (PPR); Radiation: Radiotherapy (RT): Stereotactic Radiosurgery/Radiotherapy (SRS/SRT), Whole-Brain Radiotherapy (WBRT); Other: Combined Local Treatment Modalities; Other: No Local Treatment

Interventions

No Local Treatment OTHER

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.

Eligible Patients

Neurosurgical Resection (NRS): En-bloc (EBR), Total piecemeal (TPR), Subtotal (SPR) or Partial (PPR) PROCEDURE

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

Eligible Patients

Radiotherapy (RT): Stereotactic Radiosurgery/Radiotherapy (SRS/SRT), Whole-Brain Radiotherapy (WBRT) RADIATION

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.

Eligible Patients

Combined Local Treatment Modalities OTHER

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)

Eligible Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (15)

Gomel Regional Clinical Oncology Dispensary (OKOD)

Homyel, 246012, Belarus

Location

Kaliningrad Regional Clinical Oncology Center

Kaliningrad, 236016, Russia

Location

Moscow Regional Oncology Hospital No. 62

Krasnogorsk, 143442, Russia

Location

A.S. Loginov Moscow Clinical Scientific Center

Moscow, 111123, Russia

Location

S.S. Yudin City Clinical Hospital, Oncology Center No. 1

Moscow, 115446, Russia

Location

Blokhin's Russian Cancer Research Center

Moscow, 115478, Russia

Location

OncoStop CyberKnife Center

Moscow, 115478, Russia

Location

Moscow Multidisciplinary Clinical Center "Kommunarka"

Moscow, 117303, Russia

Location

Gamma Knife Center Moscow

Moscow, 125047, Russia

Location

N.N. Burdenko National Medical Research Center of Neurosurgery

Moscow, 125047, Russia

Location

P.A. Hertsen Moscow Oncology Research Institute

Moscow, 125284, Russia

Location

N.V. Sklifosovsky Research Institute for Emergency Medicine

Moscow, 129090, Russia

Location

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, 197758, Russia

Location

Federal Center of Neurosurgery

Tyumen, 625062, Russia

Location

Republican Clinical Oncology Dispensary (RCOD)

Ufa, 450054, Russia

Location

Related Publications (2)

• 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

  BACKGROUND

• 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

  BACKGROUND

Related Links

• Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer (GENCONCOR-1)

MeSH Terms

Conditions

Colorectal Neoplasms; Brain Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• David Khalafyan, MD

  Blokhin's Russian Cancer Research Center

  PRINCIPAL INVESTIGATOR

• Alexey Tryakin, MD, professor

  Blokhin's Russian Cancer Research Center

  STUDY CHAIR

• Ali Bekyashev, MD, professor

  Blokhin's Russian Cancer Research Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data and supporting information will become available 6 months after publication of the primary results and will remain available for 5 years following article publication.
• Access Criteria: Access will be granted to qualified academic researchers who submit a methodologically sound research proposal for use approved by an independent review committee.

Locations

BE (1); RU (14)