Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-21 @ 8:40 AM
Study NCT ID:
NCT02133612
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2014-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111043', 'term': 'TP protocol'}, {'id': 'D017239', 'term': 'Paclitaxel'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-13', 'studyFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': '5 year'}], 'primaryOutcomes': [{'measure': '3 year overall survival', 'timeFrame': '5 year'}], 'secondaryOutcomes': [{'measure': '3 year disease-free survival', 'timeFrame': '5 year'}]}, 'conditionsModule': {'keywords': ['esophageal cancer', 'adjuvant chemotherapy', 'esophageal surgery', 'paclitaxel', 'cisplatin'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.\n\n* Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.\n* No standard postoperative adjuvant chemotherapy has ever been established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to give informed consent\n* histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins\n* node-positive and pathologic stage M0 .\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Patients were enrolled 4 to 10 weeks after surgery.\n* Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\\<2 times of upper normal institutional limits.\n\nExclusion Criteria:\n\n* prior chemotherapy or concurrent radiation therapy before esophagectomy\n* R1 or R2 resection\n* clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination'}, 'identificationModule': {'nctId': 'NCT02133612', 'briefTitle': 'Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer', 'orgStudyIdInfo': {'id': 'CH-GI-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm paclitaxel and cisplatin', 'interventionNames': ['Drug: paclitaxel; cisplatin']}], 'interventions': [{'name': 'paclitaxel; cisplatin', 'type': 'DRUG', 'otherNames': ['Paclitaxel Injection, Beijing Union Pharmaceutical Factory'], 'description': 'The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.', 'armGroupLabels': ['single arm paclitaxel and cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xiao Lv', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jing Huang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Jing Huang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}