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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04545658

Acronym

PTOP-RT

Enrollment

167

Registered

2020-09-11

Start date

2020-07-16

Completion date

2020-07-31

Last updated

2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Incomplete treatment

Design outcomes

Primary

Measure	Time frame	Description
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 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).
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 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).

Countries

France

Outcome results