Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT01652820
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2012-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer
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': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'From enrollment to first response assesment', 'description': 'The final response rates were 57% (arm B) and 56.9% (arm C). Arm A not available due to early closing'}], 'secondaryOutcomes': [{'measure': 'Local control rate at 1 year', 'timeFrame': '1 year'}, {'measure': 'Time to progression', 'timeFrame': 'From enrollment to first progression date', 'description': 'Arm B: 7.6 months (m) and arm C: 9.2 m; p= 0.12)'}, {'measure': 'Overall Survival', 'timeFrame': 'From enrollment to last follow up or death', 'description': 'Arm B: 14.3 m and arm C: 14.7 m; p= 0.3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LUNG', 'DOCETAXEL', 'GEMCITABINE', 'CARBOPLATIN', 'RADIOTHERAPY'], 'conditions': ['Non Small-cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '23611405', 'type': 'DERIVED', 'citation': 'Garrido P, Rosell R, Arellano A, Andreu F, Domine M, Perez-Casas A, Cardenal F, Arnaiz Mdel M, Moran T, Morera R, Isla D, Valencia J, Cobo M, Delgado R, Garcia-Gomez R, Calvo F, Zamora J, Ramos A, Massuti B. Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study. Lung Cancer. 2013 Jul;81(1):84-90. doi: 10.1016/j.lungcan.2013.03.009. Epub 2013 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable stage IIIA or B NSCLC patients\n* WHO PS 0 or 1\n* Weight loss \\< 5 % within the last 3 months\n* At least one measurable lesion\n* Planning CT scan previous to randomization\n* Written informed consent\n\nExclusion Criteria:\n\n* Malignant effusion, supraclavicular node or SVCS\n* PTV \\> 2000 cm3\n* V20 \\> 35%\n* FEV1 and DLCO both \\< 30% or 1 liter at study entry'}, 'identificationModule': {'nctId': 'NCT01652820', 'acronym': 'GECP0008', 'briefTitle': 'Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Lung Cancer Group'}, 'officialTitle': 'Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'GECP 00-08 / TAX.ES1.209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docetaxel +Carboplatin +concomitant chemoradiation', 'description': 'Docetaxel 20 mg/m2/weekly plus carboplatin AUC 2/weekly (first, docetaxel will be administered and after that, carboplatin will be administered) and concomitant chemoradiation (total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)', 'interventionNames': ['Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day', 'Drug: Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d']}, {'type': 'EXPERIMENTAL', 'label': 'C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom', 'description': 'Docetaxel 40 mg/ m2 days 1, 8, 21 y 28 plus gemcitabine 1200 mg/ m2 days 1, 8, 21 y 28 followed by concomitant treatment Docetaxel 20 mg/m2/week plus carboplatin AUC 2/weekly and concomitant chemoradiation total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)', 'interventionNames': ['Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day', 'Drug: Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d']}], 'interventions': [{'name': 'Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day', 'type': 'DRUG', 'armGroupLabels': ['C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom', 'Docetaxel +Carboplatin +concomitant chemoradiation']}, {'name': 'Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d', 'type': 'DRUG', 'armGroupLabels': ['C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom', 'Docetaxel +Carboplatin +concomitant chemoradiation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pilar Garrido, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Ramon y Cajal (Madrid)'}, {'name': 'Rafael Rosell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germans Trias i Pujol Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Lung Cancer Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aventis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}