NCT06329648: DECIDE

Distributed Learning of Edic and CardIac Dose Effects in Lung Cancer

Not yet recruiting Last updated 26 March 2024

What this trial tests

trial in NSCLC in 20,000 participants. Not yet recruiting.

Timeline

1 June 2024

Primary endpoint
31 December 2025

1 June 2028

Quick facts

Lead sponsor	The Netherlands Cancer Institute
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	20,000
Start date	1 June 2024
Primary completion	31 December 2025
Estimated completion	1 June 2028

Conditions studied

• NSCLC — all drugs for NSCLC →

Sponsor

The Netherlands Cancer Institute

Who can join

Eligibility, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Radiation-induced cardiac substructure damage and dose constraints: a review.
   Li X, Wu Y, Wang Q, Li B, et al · · 2025 · cited 3× · PMID 40474260 · DOI 10.1186/s13014-025-02668-x