The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection)MODELSNCT06366828
Prediction Models for Complications After CRT in Esophageal Cancer
An observational study of The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection), run by University Medical Center Groningen at 8 sites in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection)
- What is being tested?
- retrospective
- How many people
- 2,000 participants
- Where
- 8 sitesNetherlands
- Study dates
- 1 Feb 2023to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with esophageal cancer, treated with nCRT between 2015-2021 in the participating centers. See eligibility criteria above.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
P. van Rossum, MD, PHD
H.W.M. van Laarhoven, MD, PHD
- Not yet recruiting
Holland PTC
Delft
Yvonne Klaver, MD, PHD
- Recruiting
UMCG
Groningen, 9715GZ
Christina Muijs, MD, PHD, 0503616161, c.t.muijs@umcg.nl
C. T. Muijs, MD, PHD
- Recruiting
Zuyderland hospital
Heerlen
Meindert Sosef, MD
- Recruiting
Maastro clinic
Maastricht, Limburg, 6229ET
M. Berbee, MD, PHD
- Recruiting
Radboud UMC
Nijmegen, Gelderland, 6525GA
H. Rutten, MD
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GE
J. Nuyttens, MD, PHD
B. Wijnhoven, MD, PHD
- Recruiting
UMCU
Utrecht, 3584CX
G Meijer, PHD
About this study
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
Read the 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.
- Being tested
- retrospective
- Keywords
- prediction models, esophageal cancer (EC)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospectiveOther
follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 and 2 year after nCRT
Mortality
Mortality
Measured: 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
Measured: 1 year after nCRT
Secondary outcomes (5)
Patient-rated dysphagia
Patient-rated dysphagia
Measured: Up to 30 days after nCRT
Patient-rated nausea
Patient-rated nausea
Measured: Up to 30 day after nCRT
Patient-rated fatigue / daily functioning
Patient-rated fatigue / daily functioning
Measured: Up to 6 months after nCRT
Hospitalization after esophagectomy (days)
Hospitalization after esophagectomy (days)
Measured: Hospitalization after esophagectomy, average 12 days
Intensive care unit stay after esophagectomy (days)
Intensive care unit stay after esophagectomy (days)
Measured: Intensive care unit stay after esophagectomy, average 1.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection)Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands, Dutch Institute for Clinical Auditing (DICA), ZorgTTP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366828
- Sponsor's protocol ID
- 11446
- Acronym
- MODELS
- Status last verified
- Apr 2024
- First submitted
- 29 Feb 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Models for Complications After CRT in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06366828
- Acronym / sponsor ID
- MODELS / 11446
- Keywords
- prediction models, esophageal cancer (EC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands, Dutch Institute for Clinical Auditing (DICA), ZorgTTP
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal cancer, treated with nCRT between 2015-2021 in the participating centers. See eligibility criteria above.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospectivefollow up | Other | – |
Primary outcome
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
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
Mortality
Time frame: 1 and 2 year after nCRT
Mortality
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
5 secondary outcomes
Patient-rated dysphagia
Time frame: Up to 30 days after nCRT
Patient-rated nausea
Time frame: Up to 30 day after nCRT
Patient-rated fatigue / daily functioning
Time frame: Up to 6 months after nCRT
Hospitalization after esophagectomy (days)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection), run by University Medical Center Groningen at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Muijs, Dr. (0503616161, c.t.muijs@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivariable NTCP models will be developed for the prediction of the following (time frame: Within 90 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.