Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT00273494
Status:
UNKNOWN
Last Update Posted:
2008-05-22
First Post:
2006-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 406}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-01'}, 'lastUpdateSubmitDate': '2008-05-21', 'studyFirstSubmitDate': '2006-01-05', 'studyFirstSubmitQcDate': '2006-01-05', 'lastUpdatePostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival'}], 'secondaryOutcomes': [{'measure': 'time to progression'}]}, 'conditionsModule': {'keywords': ['N2 disease', 'Non-small cell lung cancer', 'Surgery', 'Neoadjuvant chemotherapy'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.\n\nPatients are randomised to surgery or not.', 'detailedDescription': 'Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed by irradiation or to chemotherapy followed by irradiation.\n\nEndpoint is survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically verified NSCLC\n* Stage IIIA/N2\n* age 18-75\n* Lung function test allowing surgery\n* Mediastinoscopy performed\n\nExclusion Criteria:\n\n* Prior chemotherapy\n* Prior irradiation'}, 'identificationModule': {'nctId': 'NCT00273494', 'briefTitle': 'Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Scandinavian Neoadjuvant Phase III Study of Induction Chemotherapy Followed by Irradiation Alone or Surgery Plus Irradiation in NSCLC Stage IIIA/N2 (T1N2, T2N2, T3/N2).', 'orgStudyIdInfo': {'id': 'Surgery in NSCLC stage IIIA/N2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jens B. Sorensen, MD', 'role': 'CONTACT', 'email': 'jbsonk@rh.dk', 'phone': '35454372'}, {'name': 'Jens B. Sorensen, MD', 'role': 'CONTACT', 'phone': '35454372', 'phoneExt': 'jbsonk@rh.dk'}, {'name': 'Jens B. Sorensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. Oncology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Jens B. Sorensen, MD', 'role': 'CONTACT', 'email': 'jbsonk@rh.dk', 'phone': '35454372'}], 'overallOfficials': [{'name': 'Jens B. Sorensen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}