Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-03 @ 6:04 PM
Study NCT ID:
NCT02395705
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy Versus Surgery Alone for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 528}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival rate', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival rate', 'timeFrame': '1 years and 3 years'}, {'measure': 'Disease free survival', 'timeFrame': '5 years'}, {'measure': 'assessment in perioperation-Removal rate (R0 resection rate)', 'timeFrame': 'perioperative period', 'description': 'The R0 resection rate of two groups'}, {'measure': 'assessment in perioperation-Rate of Operative Complication', 'timeFrame': 'perioperative period', 'description': 'Complication rate after operation before discharge'}, {'measure': 'assessment in perioperation-Mortality of perioperation', 'timeFrame': 'perioperative period', 'description': 'Mortality of perioperation 20 days before operation and 30 days after operation'}, {'measure': 'assessment in perioperation-Days of Hospitalization', 'timeFrame': 'perioperative period', 'description': 'Days of Hospitalization after operation'}, {'measure': 'assessment in perioperation-Thoracic Drainage', 'timeFrame': 'perioperative period', 'description': 'Thoracic Drainage days'}, {'measure': 'assessment in perioperation-Quantity of bleeding', 'timeFrame': 'perioperative period', 'description': 'blood lose during operation'}, {'measure': 'assessment in perioperation-Time of operation', 'timeFrame': 'perioperative period', 'description': 'the time from open thoracic cavity to the closure of the thoracic cavity'}, {'measure': 'Quality of life', 'timeFrame': '1 years', 'description': 'ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30'}, {'measure': 'efficacy of neo-adjuvant chemotherapy--response rate', 'timeFrame': '1-4 days before operation', 'description': 'Criteria:Response Evaluation Criteria in Solid Tumors，RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.'}, {'measure': 'toxicities of neo-adjuvant chemotherapy', 'timeFrame': 'from chemotherapy to perioperative period', 'description': 'According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol'}, {'measure': 'prognostic factors', 'timeFrame': '5 years', 'description': 'prognostic factors for overall survival of both groups'}, {'measure': 'predictive factors', 'timeFrame': '2 years', 'description': 'predictive factors for the efficiency of neo-adjuvant chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Neoplasm']}, 'descriptionModule': {'briefSummary': 'The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.', 'detailedDescription': 'The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials.\n\nThe neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).\n2. Patients must not have received any prior anticancer therapy of esophageal carcinoma.\n3. Age ranges from 18 to 75 years.\n4. Without operative contraindication.\n5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.\n6. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).\n7. expected R0 resection.\n8. ECOG 0～2.\n9. Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.\n\nExclusion Criteria:\n\n1. Multiple primary cancer.\n2. The subject cannot understand and sign the informed consent form(ICF).\n3. Patients with concomitant hemorrhagic disease.\n4. Any un expected reason for patients can't get operation.\n5. Inability to use gastric conduit after esophagectomy because of a prior surgery.\n6. Pregnant or breast feeding.\n7. Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel."}, 'identificationModule': {'nctId': 'NCT02395705', 'briefTitle': 'Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemotherapy Paclitaxel + Cisplatin Versus Surgery Alone for Stage IIA-IIIB Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'Henan CH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neo-adjuvant chemotherapy group', 'description': 'Neo-adjuvant chemotherapy(cisplatin and paclitaxel):\n\n1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.\n2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.\n3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.\n\nSurgery:\n\n2-3weeks after Neo-adjuvant chemotherapy\n\n1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.\n2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).', 'interventionNames': ['Drug: cisplatin and paclitaxel']}, {'type': 'NO_INTERVENTION', 'label': 'Surgery alone group', 'description': 'Surgery:\n\n2-3weeks after Neo-adjuvant chemotherapy\n\n1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.\n2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).'}], 'interventions': [{'name': 'cisplatin and paclitaxel', 'type': 'DRUG', 'otherNames': ['TP'], 'description': '1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.\n2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.\n3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.', 'armGroupLabels': ['Neo-adjuvant chemotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen Uniersity Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Anyang', 'state': 'Henan', 'country': 'China', 'facility': 'Anyang cancer hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Province Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan Universitay Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Yin Li, MD.&PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-President, Director of thoracic surgery department, Henan Cancer Hospital', 'investigatorFullName': 'Yin Li', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}