Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-28 @ 6:28 PM
Study NCT ID:
NCT00003566
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020775', 'term': 'Thoracic Surgery, Video-Assisted'}], 'ancestors': [{'id': 'D013906', 'term': 'Thoracoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D020535', 'term': 'Video-Assisted Surgery'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IIIA non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Jaklitsch MT, Gu L, Harpole DH, et al.: Prospective phase II trial of pre-resection thoracoscopic (VATS) restaging following neoadjuvant therapy for IIIA(N2) non-small cell lung cancer (NSCLC): results of CALGB 39803. [Abstract] J Clin Oncol 23 (Suppl 16): A-7065, 636s, 2005.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment.\n\nPURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer.", 'detailedDescription': "OUTLINE: The purpose of this study is to test the usefulness and safety of restaging the patient's cancer by a procedure called a thoracoscopy. Restaging is a process by which physicians measure the response of the patient to treatment. The primary and secondary objectives are described below.\n\nOBJECTIVES:\n\nPrimary Objective:\n\n1\\. Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer.\n\nSecondary Objectives:\n\n1. Evaluate the safety (morbidity and mortality) of pre-resectional, thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III (N2) NSCLC.\n2. Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Histologic Documentation: All patients must have histologic documentation of Stage IIIA non-small cell lung cancer on the basis of involved N2 nodes from a documented mediastinoscopy performed prior to induction therapy. Previously treated relapsed patients are not eligible.\n2. Prior Treatment: greater than or equal to 2 cycles of chemotherapy with or without radiotherapy (greater than or equal to 40 Gy) or radiotherapy alone (greater than or equal to 40 Gy) must be completed within 60 days of registration.\n3. No distant metastatic disease or local disease progression. Patients with responding or stable local disease are eligible. Those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible.\n4. No previous intrapleural surgery on the ipsilateral side.\n5. ECOG Performance Status: 0-2'}, 'identificationModule': {'nctId': 'NCT00003566', 'briefTitle': 'Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'CALGB-39803'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CLB-39803'}, {'id': 'CDR0000066632', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'video-thorascopy + surgery', 'description': 'Patients will undergo ipsilateral video-thorascopic evaluation. Patients may undergo surgery at the discretion of the surgeon and treating physicians.', 'interventionNames': ['Procedure: videothoracoscopy']}], 'interventions': [{'name': 'videothoracoscopy', 'type': 'PROCEDURE', 'armGroupLabels': ['video-thorascopy + surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northeast Alabama Regional Medical Center', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20307-5000', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Washington, DC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward General Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Regional Hospital Comprehensive Cancer Center', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CCOP - Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Chicago (Westside Hospital)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Louis A. Weiss Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60305', 'city': 'River Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'West Suburban Center for Cancer Care', 'geoPoint': {'lat': 41.89781, 'lon': -87.81395}}, {'zip': '61108', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Saint Anthony Medical Center', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '46885-5099', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology and Hematology, Incorporated', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '52242-1009', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Hospital East - Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Marlene and Stewart Greenebaum Cancer Center, University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - 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