Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 1:05 PM
Study NCT ID:
NCT00003159
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable 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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival'}], 'secondaryOutcomes': [{'measure': 'Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter'}, {'measure': 'Clinical and post-surgery pathological staging at pre-randomization'}, {'measure': 'Resectability rates'}, {'measure': 'Extent of surgery'}, {'measure': 'Time to and site of relapse'}, {'measure': 'Tumor response to chemotherapy'}, {'measure': 'Adverse effects of chemotherapy'}]}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage 0 non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '17544497', 'type': 'RESULT', 'citation': 'Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet. 2007 Jun 9;369(9577):1929-37. doi: 10.1016/S0140-6736(07)60714-4.'}, {'type': 'RESULT', 'citation': 'Hopwood P, Nankivell M, Pugh C, et al.: Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9020, 498s, 2007.'}, {'type': 'RESULT', 'citation': 'Nicolson M, Gilligan D, Smith I, et al.: Pre-operative chemotherapy in patients with resectable non-small cell lung cancer (NSCLC): first results of the MRC LU22/NVALT/EORTC 08012 multi-centre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7518, 389s, 2007.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.\n\nPURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.\n\nSecondary\n\n* Compare the quality of life of patients treated with these regimens.\n* Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.\n* Compare resectability rates in patients treated with these regimens.\n* Compare time to and site of relapse in patients treated with these regimens.\n* Determine response in patients treated with preoperative chemotherapy.\n* Determine the adverse effects of preoperative chemotherapy in these patients.\n\nOUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.\n* Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization:\n\n * Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1.\n * Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1.\n * Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8.\n * Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1.\n * Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1.\n * Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy.\n\nQuality of life is assessed at 6 and 12 months and then annually thereafter.\n\nPatients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven non-small cell lung cancer\n\n * Resectable disease\n * Previously untreated disease\n* No evidence of distant metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,000/mm\\^3\n* Neutrophil count greater than 1,500/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Considered fit for chemotherapy and surgical resection\n* No other disease or prior malignancy that would preclude study treatment\n* No active infection\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis)\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No concurrent hormonal agents, except corticosteroids\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No other concurrent anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00003159', 'briefTitle': 'Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage', 'orgStudyIdInfo': {'id': 'CDR0000065952'}, 'secondaryIdInfos': [{'id': 'MRC-LU22'}, {'id': 'EORTC-08012'}, {'id': 'EU-97016'}, {'id': 'ISRCTN25582437'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'ifosfamide', 'type': 'DRUG'}, {'name': 'mitomycin C', 'type': 'DRUG'}, {'name': 'paclitaxel', 'type': 'DRUG'}, {'name': 'vinblastine sulfate', 'type': 'DRUG'}, {'name': 'vinorelbine tartrate', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2DA', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Medical Research Council Clinical Trials Unit', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Adrian Hodson', 'affiliation': 'Medical Research Council'}, {'name': 'Ian E. Smith, MD', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}]}}}