Clinical trial · Observational
Local Treatment Strategies for Brain Metastases of Colorectal Cancer
Local Treatment Strategies for Brain Metastases of Colorectal Cancer: An International Observational Multicenter Retrospective Cohort Study (COLBRAIN)
NCT07448662CI-TRIAL-00104634COLBRAINactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Local Treatment Modalities | Other | — | UNRESOLVED |
| Neurosurgical Resection (NRS): En-bloc (EBR), Total piecemeal (TPR), Subtotal (SPR) or Partial (PPR) | Procedure | — | UNRESOLVED |
| No Local Treatment | Other | — | UNRESOLVED |
| Radiotherapy (RT): Stereotactic Radiosurgery/Radiotherapy (SRS/SRT), Whole-Brain Radiotherapy (WBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Eligible Patients
- description
- Adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases
- interventionNames
- 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
Primary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
- From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years (censored)
- description
- Time from the date of brain metastasis diagnosis to the date of death from any cause or last follow-up (censored)
- measure
- Time to Intracranial Progression (TTIP)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUND33P Molecular-genetic concordance of the primary tumor and brain metastases of colorectal cancer (GENCONCOR-1). Khalafyan, D. et al. ESMO Open, Volume 9, 103779
- BACKGROUND484P. 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