Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT05883735
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late toxicity of radiotherapy', 'timeFrame': 'up to 2 years after tomotherapy treatment', 'description': 'according to CTCAE v5.0 grading'}], 'secondaryOutcomes': [{'measure': 'acute toxicity of radiotherapy', 'timeFrame': '6 months following tomotherapy treatment', 'description': 'according to CTCAE v5.0 grading'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tomotherapy', 'Toxicity'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage II-III non-small cell or small cell lung cancer treated with normo-fractionated radiotherapy of 66Gy in 33 fractions using Tomotherapy\n\nExclusion Criteria:\n\n* patient who refused to be included in the study.'}, 'identificationModule': {'nctId': 'NCT05883735', 'acronym': 'ETRICAPT', 'briefTitle': 'Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy', 'orgStudyIdInfo': {'id': '2023-05Obs-CHRMT'}}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz-Thionville/Hopital de Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}], 'overallOfficials': [{'name': 'Xavier MICHEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital de Mercy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}