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Clinical Trials/NCT04545658
NCT04545658
Completed
Not Applicable

Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy for Lung Cancer Management

University Hospital, Brest1 site in 1 country167 target enrollmentJuly 16, 2020
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
University Hospital, Brest
Enrollment
167
Locations
1
Primary Endpoint
Prediction of Acute Pulmonary Toxicity
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

(Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.

Registry
clinicaltrials.gov
Start Date
July 16, 2020
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy

Exclusion Criteria

  • Incomplete treatment

Outcomes

Primary Outcomes

Prediction of Acute Pulmonary Toxicity

Time Frame: Up to 6 months

The model's performance will be evaluated based on the observed rate of Acute Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).

Prediction of Late Oesophageal Toxicity

Time Frame: Between 6 months and 2 years after radiotherapy

The model's performance will be evaluated based on the observed rate of Late Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).

Prediction of Acute Oesophageal Toxicity

Time Frame: Up to 6 months

The model's performance will be evaluated based on the observed rate of Acute Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).

Prediction of Late Pulmonary Toxicity

Time Frame: Between 6 months and 2 years after radiotherapy

The model's performance will be evaluated based on the observed rate of Late Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).

Study Sites (1)

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