Prediction Models for Complications After CRT in Esophageal Cancer

NCT06366828 | Recruiting

• 1 other identifier: 11446
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 8

Brief Summary

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

The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection)

Keywords

prediction models; esophageal cancer (EC)

Outcome Measures

Primary Outcomes (4)

• Multivariable NTCP models will be developed for the prediction of the following

  Postoperative complications (graded by ECCG classification (3) ): Atrial fibrillation ≥grade 2 Pneumonia ≥grade 2 Respiratory failure requiring re-intubation Anastomotic leakage ≥ grade 2

  Within 90 days after surgery

• Cardiac events grade II or higher (CTCAE v 5.0), including:

  Pericardial effusion Myocardial infarction and other acute coronary events Heart failure Pericardial effusion Myocardial infarction and other acute coronary events Heart failure Atrial fibrillation

  1 and 2 year after nCRT

• Mortality

  Mortality

  1 and 2 year after nCRT

• Complication Sum Score, that will be determined in Delphi consensus

  Complication Sum Score, that will be determined in Delphi consensus

  1 year after nCRT

Secondary Outcomes (5)

• Patient-rated dysphagia

  Up to 30 days after nCRT

• Patient-rated nausea

  Up to 30 day after nCRT

• Patient-rated fatigue / daily functioning

  Up to 6 months after nCRT

• Hospitalization after esophagectomy (days)

  Hospitalization after esophagectomy, average 12 days

• Intensive care unit stay after esophagectomy (days)

  Intensive care unit stay after esophagectomy, average 1.5 days

Interventions

retrospective OTHER

follow up

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal cancer, treated with nCRT between 2015-2021 in the participating centers. See eligibility criteria above.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Cancer Society: collaborator
• Comprehensive Cancer Centre The Netherlands: collaborator
• Dutch Institute for Clinical Auditing (DICA): collaborator
• ZorgTTP: collaborator

Study Sites (8)

Radboud UMC

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Maastro clinic

Maastricht, Limburg, 6229ET, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015GE, Netherlands

RECRUITING

Holland PTC

Delft, Netherlands

NOT YET RECRUITING

UMCG

Groningen, 9715GZ, Netherlands

RECRUITING

Zuyderland hospital

Heerlen, Netherlands

RECRUITING

UMCU

Utrecht, 3584CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Christina Muijs, Dr.

CONTACT

0503616161; c.t.muijs@umcg.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: April 16, 2024
• Study Start: February 1, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

NL (8)