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

(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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Brest

Brest, Finistère, 29200, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Incomplete treatment

Treatment and study plan

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 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).
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 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PTOP-RT

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Sep 11, 2020
Registry last updated: Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed