Prediction Models for Complications After CRT in Esophageal Cancer
NCT ID: NCT06366828
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2023-02-01
2030-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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retrospective
follow up
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who underwent a surgical resection in a non-participating surgical center will be excluded
18 Years
100 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Comprehensive Cancer Centre The Netherlands
OTHER
Dutch Institute for Clinical Auditing (DICA)
UNKNOWN
ZorgTTP
UNKNOWN
University Medical Center Groningen
OTHER
Responsible Party
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Locations
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Radboud UMC
Nijmegen, Gelderland, Netherlands
Maastro clinic
Maastricht, Limburg, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
Holland PTC
Delft, , Netherlands
UMCG
Groningen, , Netherlands
Zuyderland hospital
Heerlen, , Netherlands
UMCU
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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H. Rutten, MD
Role: primary
M. Berbee, MD, PHD
Role: primary
P. van Rossum, MD, PHD
Role: primary
J. Nuyttens, MD, PHD
Role: primary
Yvonne Klaver, MD, PHD
Role: primary
Meindert Sosef, MD
Role: primary
G Meijer, PHD
Role: primary
Other Identifiers
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11446
Identifier Type: -
Identifier Source: org_study_id
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