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NCT05883735 Clinical Trial

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

Lung Cancer Clinical Trial

— ETRICAPT  

Official title:
Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05883735
Other study ID # 2023-05Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date December 1, 2023

Study information
Verified date January 2024
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 318
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHR Metz-Thionville/Hopital de Mercy Metz

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary late toxicity of radiotherapy according to CTCAE v5.0 grading up to 2 years after tomotherapy treatment
Secondary acute toxicity of radiotherapy according to CTCAE v5.0 grading 6 months following tomotherapy treatment
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