- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06329648
Distributed Learning of Edic and CardIac Dose Effects in Lung Cancer (DECIDE)
Cardiac dose was not a major concern in lung radiotherapy patients until the results of the RTOG (Radiation Therapy Oncology Group) 0617 trial, which showed an association between cardiac dose and survival. Since then, many papers have studied the association between cardiac (substructure) dose and either survival or cardiac toxicity. Ideally, cardiac toxicity would be separated from survival. However, scoring cardiac toxicity prospectively was not standard practice, and retrospective scoring is challenging because of the overlap of cardiac toxicity symptoms and lung cancer (treatment) symptoms. Therefore in real world cohorts, cardiac toxicity is usually not scored properly and most larger studies pragmatically consider overall survival as primary endpoint, and the relation between cardiac dose and cardiac toxicity is not well established for lung cancer patients.
Cardiac toxicity might not be the only factor in decreased survival; toxicity of the immune system might be a competing risk or a major contributing factor, where dose to the heart is a surrogate for dose to blood. Dose to the immune system is defined as EDIC (Effective Dose to circulating Immune Cells), comprising heart dose, lung dose and body dose combined. As EDIC dose and cardiac dose partly overlap, a large cohort with substantial variation will be required to disentangle the two effects. Such vast amounts of routine care data are immediately available in many radiotherapy centers all over the world. The problem we face is not the lack of routine care data, but making such data available for analysis. DECIDE adopts a federated learning approach, which implies that data does not have to be centralized within a single institution to be fit for use. We aim to include an unprecedentedly large-scale cohort of 20,000 patients.
In this proposal, we need to add on scientific and technological innovations that exploit the existing federated learning framework to scale up to supporting >25 simultaneously connected partners. We will be training (generalized) linear epidemiological models as well as new computer vision-based models for outcome predictions. As cause-specific survival (cardiac toxicity or immune toxicity) is unavailable or unreliable in major studies, we will use the more pragmatic endpoint of survival. By elucidating the clinical contributions of whole heart dose, cardiac substructure dose and EDIC dose in combination with known clinical risk factors, the desired impact is to change clinical practice for lung cancer radiotherapy and improve survival.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tomas Janssen, PhD
- Phone Number: +31205122164
- Email: t.janssen@nki.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pathologically confirmed primary diagnosis of non-small cell lung cancer (NSCLC) stage I - III
- Subjects must have been treated by primary radiotherapy - e.g. 3D-conformal, intensity modulated, arc therapy or stereotactic body radiotherapy - and either with or without chemotherapy.
- Mandatory data elements (see below) are available
Exclusion Criteria:
- Subjects under 18 years of age.
- Vulnerable groups or individuals (as per WMA Helsinki Declaration) that have not given consent to be treated with radiotherapy by a qualified physician at the participating centre.
- Primary cancer was not NSCLC or SCLC.
- Surgical resection of lung (wedge, lobectomy, etc.) prior to radiotherapy.
- CT studies and corresponding GTV delineations were previously made publicly available via open access data repositories.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimize EDIC dose
Time Frame: 4 years
|
- Optimize the relative contribution of the different components of the EDIC dose, with overall survival as endpoint.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiac toxicity
Time Frame: 4 years
|
- Depending on the optional data available we will explicitly model cardiac toxicity and hematological toxicity
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Stam, PhD, The Netherlands Cancer Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DECIDE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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