Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06550518
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Time from epirubicin-paclitaxel regimen initiation to disease progression (according to Response Evaluation Criteria In Solid Tumors v1.1) or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year', 'description': 'Time from epirubicin-paclitaxel regimen initiation to death from any cause'}, {'measure': 'Objective response rate', 'timeFrame': '1 year', 'description': 'Complete response or partial response (according to Response Evaluation Criteria In Solid Tumors v1.1)'}, {'measure': 'Disease control rate', 'timeFrame': '1 year', 'description': 'Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)'}, {'measure': 'Intracranial control rate', 'timeFrame': '1 year', 'description': 'Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)'}, {'measure': 'Toxicities', 'timeFrame': '1 year', 'description': 'According to Common Toxicity Criteria for Adverse Events version 5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small-cell Lung Cancer', 'Epirubicin', 'Paclitaxel', 'Cerebral Efficacy', 'Real-life'], 'conditions': ['Advanced Small Cell Lung Carcinoma']}, 'descriptionModule': {'briefSummary': 'Initial chemosensitivity is known concerning SCLC but relapse is almost systematic, especially at a metastatic stage. Brain metastasis are identified around 40 to 50% during the evolution of the disease. Concerning the efficacy of epirubicin combined with paclitaxel from the second-line treatment, data is lacking more particularly about specific response on brain metastasis.\n\nIn this retrospective multicentric observational study in real life conditions, we try to evaluate systemic and specific cerebral efficacy and safety of a regimen combining epirubicin and paclitaxel in patients treated between 2010 and 2020 for a small cell lung carcinoma from the second-line treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (age ≥18 years) with histologically or cytologically SCLC diagnosis was confirmed who received at least one cycle with a epirubicin-paclitaxel doublet treated between January 2010 and December 2020 in one of the three centers (Brest University Hospital Center, Quimper Hospital Center and Landerneau Hospital Center)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* Histologically or cytologically SCLC diagnosis\n* Treated with epirubicin-paclitaxel doublet between January 2010 and December 2020\n\nExclusion Criteria:\n\n* Opposition to participate registered\n* Patients under legal protection\n* Patients afflicted by another subtype of lung carcinomas\n* SCLC not treated with the epirubicin-paclitaxel doublet'}, 'identificationModule': {'nctId': 'NCT06550518', 'acronym': 'EPITAX', 'briefTitle': 'Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study', 'orgStudyIdInfo': {'id': '29BRC21.0086 - EPITAX'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29800', 'city': 'Landerneau', 'country': 'France', 'facility': 'Hôpital de Landerneau', 'geoPoint': {'lat': 48.4515, 'lon': -4.25175}}, {'zip': '29000', 'city': 'Quimper', 'country': 'France', 'facility': 'CHIC', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three month and ending five years following the publication', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}