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

NCT04545658 | Completed

• 1 other identifier: PTOP-RT (29BRC20.0154)
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Prediction of Acute Pulmonary Toxicity

  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).

  Up to 6 months

• Prediction of Late Pulmonary Toxicity

  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).

  Between 6 months and 2 years after radiotherapy

• Prediction of Acute Oesophageal Toxicity

  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).

  Up to 6 months

• Prediction of Late Oesophageal Toxicity

  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).

  Between 6 months and 2 years after radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage I, II, III lung cancer patients treated with (chemo)-radiotherapy

You may qualify if:

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

You may not qualify if:

• Incomplete treatment

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, Finistère, 29200, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: September 11, 2020
• Study Start: July 16, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-07

Locations

FR (1)