Clinical trial · Observational
The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
- 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)
The incidence of brain metastases is expected to increase because of better treatments of primary tumours. Novel diagnostic and therapeutic techniques are continuously being developed, all of which need thorough evaluation before they can be implemented in clinical routine. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. .The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard. This design will speed up the process of translating treatment innovations to the daily clinic.
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 | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Brain Neoplasms, Adult, Malignant | Adult Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Survival
- timeFrame
- Through study completion, an average of 1 year
- description
- Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Basisregistratie Personen (BRP))
- measure
- Time and Type of re-intervention
- timeFrame
- Through study completion, an average of 1 year
- description
- Re-intervention (re-irradiation, surgery, other); Development of neurological symptoms; Development of new metastases.
- measure
- Change in toxicity after radiotherapy
- timeFrame
- Through study completion, an average of 1 year
- description
- The toxicity will be reported by using the serious adverse event (SAE) questionnaire, every 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years; * Either radiographic and/or histologic proof of metastatic brain disease, or eligible for prophylactic cranial irradiation; * Referred to the Department of Radiotherapy for cranial irradiation. Exclusion Criteria: * Mental disorder or cognitive dysfunction that hinder the patient's ability to understand the informed consent procedure and/or study details; * Patients with severe psychiatric disorders; * Inability to understand the Dutch language.
References
Publications (0)
Data not yet available