Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01494558
Status:
COMPLETED
Last Update Posted:
2011-12-19
First Post:
2011-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat 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': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-16', 'studyFirstSubmitDate': '2011-12-14', 'studyFirstSubmitQcDate': '2011-12-16', 'lastUpdatePostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Overall survival'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '32252680', 'type': 'DERIVED', 'citation': 'Bi N, Liu L, Liang J, Wu S, Chen M, Lv C, Zhao L, Shi A, Jiang W, Xu Y, Zhou Z, Wang J, Wang W, Chen D, Hui Z, Lv J, Zhang H, Feng Q, Xiao Z, Wang X, Zhang T, Yin W, Li J, He J, Wang L. Efficacy and safety of concurrent chemoradiotherapy in ECOG 2 patients with locally advanced non-small-cell lung cancer: a subgroup analysis of a randomized phase III trial. BMC Cancer. 2020 Apr 6;20(1):278. doi: 10.1186/s12885-020-06780-x.'}, {'pmid': '28137739', 'type': 'DERIVED', 'citation': 'Liang J, Bi N, Wu S, Chen M, Lv C, Zhao L, Shi A, Jiang W, Xu Y, Zhou Z, Wang W, Chen D, Hui Z, Lv J, Zhang H, Feng Q, Xiao Z, Wang X, Liu L, Zhang T, Du L, Chen W, Shyr Y, Yin W, Li J, He J, Wang L. Etoposide and cisplatin versus paclitaxel and carboplatin with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer: a multicenter randomized phase III trial. Ann Oncol. 2017 Apr 1;28(4):777-783. doi: 10.1093/annonc/mdx009.'}]}, 'descriptionModule': {'briefSummary': 'Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB). It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over 30min weekly). The primary purpose is to evaluate objective response rate, complications, progression-free survival, overall survival. The second purpose is to evaluate quality of life and cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inoperable stage IIIA/IIIB NSCLC proved by pathology or cytology\n2. Age 18 to 75, ECOG ≤ 2, lose weight \\<10% during 6 months\n3. No serious diseases of important organs\n4. Chest CT in recently 4 weeks\n5. No other tumor disease except stage I cervical cancer or cutaneous basal cell carcinoma\n6. Sign consent\n7. Measurable lesion\n\nExclusion Criteria:\n\n1. Pretreatment radiotherapy or chemotherapy\n2. Pregnant or lactation woman\n3. Serious diseases (include uncontrolled diabetes and infection) of important organs\n4. Psychopath\n5. Join in other clinical trial'}, 'identificationModule': {'nctId': 'NCT01494558', 'briefTitle': 'Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Phase 3 Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy in Patients With Unresectable Locally Advanced, Stage III Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2006BAI02A02[1]-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PE concurrent chemotherapy', 'description': 'Radiotherapy concurrently with PE chemotherapy', 'interventionNames': ['Other: Chemoradiotherapy Regimen between PC and PE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PC concurrent chemotherapy', 'description': 'Radiotherapy concurrently with PC chemotherapy', 'interventionNames': ['Other: Chemoradiotherapy Regimen between PC and PE']}], 'interventions': [{'name': 'Chemoradiotherapy Regimen between PC and PE', 'type': 'OTHER', 'otherNames': ['Chemoradiotherapy'], 'description': 'etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy', 'armGroupLabels': ['PC concurrent chemotherapy', 'PE concurrent chemotherapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'luhua Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Cancer Hospital & Institution, CAMS & PUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of Thoracic Group, Clinical Professor, Radiation Oncology Department, Cancer Hospital&Institute', 'investigatorFullName': 'Luhua Wang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}