Developing models to predict complications after treatment for esophageal cancer
Prediction Models for Complications After CRT in Esophageal Cancer
This study is trying to create tools that can predict complications after treatment for esophageal cancer to help doctors choose the best care for their patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 8 sites (Nijmegen, Gelderland and 7 other locations) |
| Trial ID | NCT06366828 on ClinicalTrials.gov |
What this trial studies
This project aims to develop and validate prediction models for complications following neoadjuvant chemoradiotherapy (nCRT) and surgical resection in patients with esophageal cancer. The study will evaluate two strategies: creating separate models for various complications and a composite model that summarizes all complications into a single score. By linking data from existing cancer registries and a radiotherapy database, the study will analyze over 2000 patient records to optimize radiotherapy planning and improve patient selection. The goal is to enhance treatment outcomes by predicting potential complications more accurately.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed esophageal cancer who have undergone nCRT and are planned for or have had an esophagectomy.
Not a fit: Patients with sarcoma, neuro-endocrine, or small cell carcinoma of the esophagus will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment planning and reduced complications for patients with esophageal cancer.
How similar studies have performed: Other studies have shown promise in developing predictive models for cancer treatment complications, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nijmegen, Gelderland and 7 other locations
- Radboud UMC — Nijmegen, Gelderland, Netherlands (Recruiting)
- Maastro clinic — Maastricht, Limburg, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
- Holland PTC — Delft, Netherlands (Not_yet_recruiting)
- Umcg — Groningen, Netherlands (Recruiting)
- Zuyderland hospital — Heerlen, Netherlands (Recruiting)
- Umcu — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Christina Muijs, Dr.
- Email: c.t.muijs@umcg.nl
- Phone: 0503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.