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

Completed

• Conditions: Lung Cancer

• Registration Number: NCT04545658
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-16
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Study First Posted: 2020-09-11
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

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

Exclusion Criteria

• Incomplete treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction of Acute Pulmonary Toxicity	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	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	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	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).

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, Finistère, France