Clinical trial NCT06366828: Prediction Models for Complications After CRT in Esophageal Cancer
Official title: Prediction Models for Complications After CRT in Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Comprehensive Cancer Centre The Netherlands
name: Dutch Institute for Clinical Auditing (DICA)
name: ZorgTTP
First posted: 2024-04-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility 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

Primary outcomes:
measure: Multivariable NTCP models will be developed for the prediction of the following
timeFrame: Within 90 days after surgery
measure: Cardiac events grade II or higher (CTCAE v 5.0), including:
timeFrame: 1 and 2 year after nCRT
measure: Mortality
timeFrame: 1 and 2 year after nCRT
measure: Complication Sum Score, that will be determined in Delphi consensus
timeFrame: 1 year after nCRT
Secondary outcomes:
measure: Patient-rated dysphagia
timeFrame: Up to 30 days after nCRT
measure: Patient-rated nausea
timeFrame: Up to 30 day after nCRT
measure: Patient-rated fatigue / daily functioning
timeFrame: Up to 6 months after nCRT
measure: Hospitalization after esophagectomy (days)
timeFrame: Hospitalization after esophagectomy, average 12 days
measure: Intensive care unit stay after esophagectomy (days)
timeFrame: Intensive care unit stay after esophagectomy, average 1.5 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMC
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastro clinic
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Delft
country: Netherlands
facility: Holland PTC
city: Groningen
country: Netherlands
facility: UMCG
city: Heerlen
country: Netherlands
facility: Zuyderland hospital
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
References: