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

NCT05883735 | Completed

• 1 other identifier: 2023-05Obs-CHRMT
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

Tomotherapy; Toxicity

Outcome Measures

Primary Outcomes (1)

• late toxicity of radiotherapy

  according to CTCAE v5.0 grading

  up to 2 years after tomotherapy treatment

Secondary Outcomes (1)

• acute toxicity of radiotherapy

  6 months following tomotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• patient who refused to be included in the study.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xavier MICHEL, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 1, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

FR (1)