Clinical trial · Observational
Prediction Models for Complications After CRT in Esophageal Cancer
NCT06366828CI-TRIAL-00076117MODELSrecruitingClinicalTrials.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)
The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| retrospective | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Multivariable NTCP models will be developed for the prediction of the following
- timeFrame
- Within 90 days after surgery
- description
- Postoperative complications (graded by ECCG classification (3) ): Atrial fibrillation ≥grade 2 Pneumonia ≥grade 2 Respiratory failure requiring re-intubation Anastomotic leakage ≥ grade 2
- measure
- Cardiac events grade II or higher (CTCAE v 5.0), including:
- timeFrame
- 1 and 2 year after nCRT
- description
- Pericardial effusion Myocardial infarction and other acute coronary events Heart failure Pericardial effusion Myocardial infarction and other acute coronary events Heart failure Atrial fibrillation
- measure
- Mortality
- timeFrame
- 1 and 2 year after nCRT
- description
- Mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor in the esophagus, histologically proven or suspect for esophageal carcinoma * WHO performance 0-2 * Age\>18years * No distant metastasis (M0) * Treated with nCRT and planned for or followed by an esophagectomy between 2015 and 2021 in one of the participating centers. Exclusion Criteria: * Sarcoma, neuro-endocrine or small cell carcinoma of the esophagus * Patients who underwent a surgical resection in a non-participating surgical center will be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.