Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy (ETRICAPT)

January 8, 2024 updated by: Centre Hospitalier Régional Metz-Thionville

Lung cancers treated by Tomotherapy represent between 60 and 100 patients per year at the CHR of Metz-Thionville. Some patients were observed to present acute toxicities during treatment such as dysphagia or esophagitis of CTCAE grade > 2. Beyond well known therapeutic and comorbidities factors, the pathophysiology of these events is largely ruled by a constitutional factor - the enzymatic equipment allowing more or less good repair of the DNA lesions induced by radiotherapy (RT). This equipment is characteristic of each individual, hence the term individual radiosensitivity (IR).The scientific literature is rather poor in data describing the frequency of these toxicities in patients receiving RT for lung cancer.

The objective of this study is to describe the frequency of acute and late toxicities after normofractionated radiotherapy of 66 Gy in 33 fractions in patients with small cell or non-small cell lung cancer, stage 2 or 3.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Metz, France, 57085
        • CHR Metz-Thionville/Hopital de Mercy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The cohort will consist of patients with stage II-III non-small cell or small cell lung cancer (ICD-10 code: C34) treated with normo-fractionated radiotherapy of 66 Gy in 33 fractions using Tomotherapy between January 2016 and April 2023 at CHR Metz-Thionville.

Description

Inclusion Criteria:

  • stage II-III non-small cell or small cell lung cancer treated with normo-fractionated radiotherapy of 66Gy in 33 fractions using Tomotherapy

Exclusion Criteria:

  • patient who refused to be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late toxicity of radiotherapy
Time Frame: up to 2 years after tomotherapy treatment
according to CTCAE v5.0 grading
up to 2 years after tomotherapy treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute toxicity of radiotherapy
Time Frame: 6 months following tomotherapy treatment
according to CTCAE v5.0 grading
6 months following tomotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Xavier MICHEL, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-05Obs-CHRMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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