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Completed

NCT Number: NCT05883735

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. late toxicity of radiotherapy

    Time frame: up to 2 years after tomotherapy treatment

    according to CTCAE v5.0 grading

Secondary outcomes

  1. acute toxicity of radiotherapy

    Time frame: 6 months following tomotherapy treatment

    according to CTCAE v5.0 grading

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Acronym: ETRICAPT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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