Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT00321334
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2006-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2006-05-01', 'studyFirstSubmitQcDate': '2006-05-01', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 years Disease Free Survival (at end of 3 years)', 'timeFrame': 'Prospective'}], 'secondaryOutcomes': [{'measure': '3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)', 'timeFrame': 'Prospective'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'Chemotherapy', 'surgery', 'neo-adjuvant', 'adjuvant', 'RCT'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin) after complete operation will improve survival when compared with 3 cycles of TP prior to complete resection for NSCLC.', 'detailedDescription': 'Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed worldwide. Surgical resection offers the best chance for cure for those patients diagnosed with early-stage disease, however, the vast majority of patients experience eventually relapse or metastasis. The rationale of neoadjuvant or adjuvant chemotherapy for early stage NSCLC lies in the possibility of eradicating micro-metastasis disease, so it appears to improve survival by reducing the occurrence of distant metastases. Meta analysis, CALGB 9633, JBR 10 and ANITA trials have shown postoperative (adjuvant) CT after complete resection will prolong survival. On the other hand, Depierre et al had conducted a trial to demonstrate preoperative (neoadjuvant ) chemotherapy in early stage NSCLC appears to improve survival. We need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which treatment model is better to early stager NSCLC. Based on proven activity and survival benefit in advance NSCLC, docetaxel has been introduced into neoadjuvant therapy, even as a potential option in adjuvant setting.\n\nComparison: 3 cycles of TP after complete operation compared to 3 cycles of TP prior to complete resection for NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer patients,without previous chemotherapy, radiotherapy or target-therapy;\n* age from 18 to 75;\n* PS with ECOC 0-1;\n* Adequate haematological and Hepatic- renal function;\n* Expected to live longer than 12 months;\n* The informed consent should be signed.\n\nExclusion Criteria:\n\n* Patients with Small Cell Lung Cancer;\n* Already receiving any prior anti-cancer treatment;\n* Pregnant women;\n* Uncontrolled diabetes, mental disease;\n* Hepatic and renal function failure;\n* The investigators believe the patient is not suitable to be enrolled in the study'}, 'identificationModule': {'nctId': 'NCT00321334', 'briefTitle': 'Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Society of Lung Cancer'}, 'officialTitle': 'Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer', 'orgStudyIdInfo': {'id': 'CSLC0501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Docetexel', 'description': 'Chemotherapy+Surgery', 'interventionNames': ['Procedure: Chemotherapy+Surgery']}], 'interventions': [{'name': 'Chemotherapy+Surgery', 'type': 'PROCEDURE', 'description': 'Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles', 'armGroupLabels': ['Docetexel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Chinese Society of Lung Cancer', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yi-Long Wu, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Society of Lung Cancer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yi-Long Wu', 'investigatorAffiliation': 'Chinese Society of Lung Cancer'}}}}