Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-04-19 @ 1:07 AM
Study NCT ID:
NCT02966769
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2016-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-15', 'studyFirstSubmitDate': '2016-11-11', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '5 years'}, {'measure': 'Patterns of Relapse', 'timeFrame': '5 years'}, {'measure': 'Mortality', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-small-Cell Lung Carcinoma', 'Surgery', 'Stage IIIA-N2', 'Chemoradiation', 'Survival']}, 'descriptionModule': {'briefSummary': 'The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation.\n\nSecondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.', 'detailedDescription': 'Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment.\n\nThe major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage IIIA (N2) disease\n* Potentially resectable disease\n* Stage Lung Cancer with CT scan or PET-CT.\n* N2 involvement: it is not necessary pathological proof.\n* No progression after induction treatment.\n\nExclusion Criteria:\n\n* T4 or N3 stage.\n* Bulky disease or not resectable.'}, 'identificationModule': {'nctId': 'NCT02966769', 'briefTitle': 'N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation', 'organization': {'class': 'OTHER', 'fullName': 'Grupo de Investigación Clínica en Oncología Radioterapia'}, 'officialTitle': 'Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2', 'orgStudyIdInfo': {'id': 'GICOR -SEOR 5-16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemoradiation Group', 'description': 'Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (\\>/= 60 Gy) plus Platinum-based Chemotherapy', 'interventionNames': ['Other: Overall survival']}, {'label': 'Neoadjuvant treatment plus Surgery Group', 'description': 'Analyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus \\>/= 45Gy) followed by Surgery', 'interventionNames': ['Other: Overall survival']}], 'interventions': [{'name': 'Overall survival', 'type': 'OTHER', 'description': 'Compare overall survival between both groups.', 'armGroupLabels': ['Chemoradiation Group', 'Neoadjuvant treatment plus Surgery Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28290', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quiron Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Felipe Couñago, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grupo de Investigación Clínica en Oncología Radioterapia'}, {'name': 'Sara Montemuiño, MDPhd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grupo de Investigación Clínica en Oncología Radioterapia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Investigación Clínica en Oncología Radioterapia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Felipe Couñago', 'investigatorAffiliation': 'Grupo de Investigación Clínica en Oncología Radioterapia'}}}}