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

Lung Cancer Clinical Trial

— PTOP-RT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04545658
• Other study ID #: PTOP-RT (29BRC20.0154)
• Status: Completed
• Start date: July 16, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Incomplete treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	CHRU Brest	Brest	Finistère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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