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

Study Overview

Status

Recruiting

Conditions

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

Intervention / Treatment

Other: retrospective

Detailed Description

Plan of investigation

In the present project we aim to evaluate two potential strategies to predict and consider a broad spectrum of complications for radiotherapy plan optimization and patient selection:

A comprehensive set of separate NTCP-models for several cardiopulmonary and post-operative complications after nCRT, which results in an NTCP-profile.

A single multivariable NTCP-model for a so-called Complication Sum Score (CSS), which is a single composite complication endpoint including all complications after nCRT, weighted depending on severity and impact.

These prediction models can be used for RT plan optimization and patient selection.

In order to develop these prediction models the project consortium brings together existing prospective data registries for esophageal cancer, namely the Dutch Upper GI Cancer Audit (DUCA) and the Dutch Cancer Registry (NKR) (as well as the POCOP study).

The data of these registries will be linked to a retrospective radiotherapy database using the ProTRAIT infrastructure, resulting in a dataset of over 2000 patients.

In this retrospective cohort study, we will focus on esophageal cancer patients who were treated with nCRT, and for whom an esophagectomy was intended. We will include the patients who received nCRT and the esophagectomy in one of the participating centers. Patients who only received nCRT in one of the participating centers and for whom surgical resection was omitted will be included as well. Detailed eligibility criteria can be found in that section.

Eligible patients will be identified by the Dutch Cancer Registry. The surviving patients will be asked to provide informed consent for participation in this study, permission to combine the different data registries and for future use of their data. Patients who died will be included as well, unless they objected agains the use of there data in the participating centers.

Of the participating patients, the radiotherapy plan-CT and treatment plans (i.e. RTplan, RT struct, RT dose), will be pseudo-anonymized, uploaded and transferred to the UMCG data platform, by the participating radiotherapy centers.

A third trusted party, Zorg TTP, will be responsible for the pseudonymization of the three data sources; the Dutch upper GI cancer audit (DUCA), the Dutch Cancer Registry (NKR) and the RTregistry. After that the linkage will be performed at the UMCG.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Christina Muijs, Dr.
Phone Number: 0503616161
Email: c.t.muijs@umcg.nl

Study Locations

Netherlands
- - Delft, Netherlands
    - Not yet recruiting
    - Holland PTC
    - Contact:
      
      Yvonne Klaver, MD, PHD
  - Groningen, Netherlands, 9715GZ
    - Recruiting
    - UMCG
    - Contact:
      
      Christina Muijs, MD, PHD
      
      Phone Number: 0503616161
      
      Email: c.t.muijs@umcg.nl
    - Principal Investigator:
      
      C. T. Muijs, MD, PHD
    - Sub-Investigator:
      
      J. A. Langendijk, Prof., MD, PHD
    - Sub-Investigator:
      
      B. van Etten, MD, PHD
    - Sub-Investigator:
      
      J. J. de Haan, MD, PHD
  - Heerlen, Netherlands
    - Recruiting
    - Zuyderland hospital
    - Contact:
      
      Meindert Sosef, MD
  - Utrecht, Netherlands, 3584CX
    - Recruiting
    - UMCU
    - Contact:
      
      G Meijer, PHD
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6525GA
    - Recruiting
    - Radboud UMC
    - Contact:
      
      H. Rutten, MD
- Limburg
  - Maastricht, Limburg, Netherlands, 6229ET
    - Recruiting
    - Maastro Clinic
    - Contact:
      
      M. Berbee, MD, PHD
- Noord-Holland
  - Amsterdam, Noord-Holland, Netherlands, 1105AZ
    - Recruiting
    - Amsterdam UMC
    - Contact:
      
      P. van Rossum, MD, PHD
    - Principal Investigator:
      
      H.W.M. van Laarhoven, MD, PHD
- Zuid-Holland
  - Rotterdam, Zuid-Holland, Netherlands, 3015GE
    - Recruiting
    - Erasmus MC
    - Contact:
      
      J. Nuyttens, MD, PHD
    - Principal Investigator:
      
      B. Wijnhoven, MD, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multivariable NTCP models will be developed for the prediction of the following Time Frame: Within 90 days after surgery	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: Time Frame: 1 and 2 year after nCRT	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 Time Frame: 1 and 2 year after nCRT	Mortality	1 and 2 year after nCRT
Complication Sum Score, that will be determined in Delphi consensus Time Frame: 1 year after nCRT	Complication Sum Score, that will be determined in Delphi consensus	1 year after nCRT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-rated dysphagia Time Frame: Up to 30 days after nCRT	Patient-rated dysphagia	Up to 30 days after nCRT
Patient-rated nausea Time Frame: Up to 30 day after nCRT	Patient-rated nausea	Up to 30 day after nCRT
Patient-rated fatigue / daily functioning Time Frame: Up to 6 months after nCRT	Patient-rated fatigue / daily functioning	Up to 6 months after nCRT
Hospitalization after esophagectomy (days) Time Frame: Hospitalization after esophagectomy, average 12 days	Hospitalization after esophagectomy (days)	Hospitalization after esophagectomy, average 12 days
Intensive care unit stay after esophagectomy (days) Time Frame: Intensive care unit stay after esophagectomy, average 1.5 days	Intensive care unit stay after esophagectomy (days)	Intensive care unit stay after esophagectomy, average 1.5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Comprehensive Cancer Centre The Netherlands

Dutch Cancer Society

Dutch Institute for Clinical Auditing (DICA)

ZorgTTP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

April 14, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)