Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02459457
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2015-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2015-05-23', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '1year, 2 years, 3 years'}, {'measure': 'adverse event', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['esophageal squamous cell carcinoma', 'concurrent chemoradiotherapy', 'paclitaxel', 'cisplatin', 'carboplatin', 'fluorouracil'], 'conditions': ['Stage III Esophageal Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '35188552', 'type': 'DERIVED', 'citation': 'Ai D, Ye J, Wei S, Li Y, Luo H, Cao J, Zhu Z, Zhao W, Lin Q, Yang H, Zheng X, Zhou J, Huang G, Li L, Li J, Zhang Z, Zhou G, Gu D, Du M, Mo M, Jia H, Zhang Z, Zhao K. Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220120. doi: 10.1001/jamanetworkopen.2022.0120.'}, {'pmid': '30344165', 'type': 'DERIVED', 'citation': 'Ai D, Chen Y, Liu Q, Zhang J, Deng J, Zhu H, Ren W, Zheng X, Li Y, Wei S, Ye J, Zhou J, Lin Q, Luo H, Cao J, Li J, Huang G, Wu K, Fan M, Yang H, Zhu Z, Zhao W, Li L, Fan J, Badakhshi H, Zhao K. Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2). BMJ Open. 2018 Oct 21;8(10):e020785. doi: 10.1136/bmjopen-2017-020785.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nTo be eligible for this study, patient must fulfill all of the following criteria:\n\n1. Histologically confirmed esophageal squamous cell carcinoma\n2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification\n3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.\n4. Aged 18-75 years\n5. Adequate organ functions\n\n 1. White blood cell (WBC) ≥3×109⁄L\n 2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L\n 3. Hemoglobin (Hb) ≥10g⁄dl\n 4. Platelet (Plt) ≥100×109⁄L\n 5. Total bilirubin \\<1.5 upper limit of normal (ULN)\n 6. Aspartate transaminase (AST) ≤2.5 ULN\n 7. Alanine aminotransferase (ALT) ≤2.5 ULN\n 8. Creatinine ≤1.5 ULN\n6. ECOG PS of 0-2\n7. Life expectancy ≥3 months\n8. Written informed consent\n\nExclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.\n\n1. Esophageal perforation or hematemesis\n2. Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)\n3. Received thoracic, abdominal or craniocerebral surgery within 30 days\n4. Enrolled in other clinical trials within 30 days\n5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months\n6. Severe psychiatric disease\n7. Pregnancy, lactation or unwillingness to adopt contraception\n8. Drug addiction\n9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition\n10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade \\> 1\n11. History of radiotherapy in the planning area\n12. Other ineligible conditions according to researchers'}, 'identificationModule': {'nctId': 'NCT02459457', 'briefTitle': 'A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial', 'orgStudyIdInfo': {'id': 'ESO-Shanghai 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel and Cisplatin (TP)', 'description': 'Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w\\*4', 'interventionNames': ['Drug: Paclitaxel and Cisplatin', 'Radiation: Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel and Fluorouracil (TF)', 'description': 'Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw\\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w\\*2', 'interventionNames': ['Drug: Paclitaxel and Fluorouracil', 'Radiation: Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel and Carboplatin（TC）', 'description': 'Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw\\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w\\*2', 'interventionNames': ['Drug: Paclitaxel and Carboplatin', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'Paclitaxel and Cisplatin', 'type': 'DRUG', 'otherNames': ['TP'], 'description': 'patients get Paclitaxel and Cisplatin according to protocol', 'armGroupLabels': ['Paclitaxel and Cisplatin (TP)']}, {'name': 'Paclitaxel and Fluorouracil', 'type': 'DRUG', 'otherNames': ['TF'], 'description': 'patients get Paclitaxel and Fluorouracil according to protocol', 'armGroupLabels': ['Paclitaxel and Fluorouracil (TF)']}, {'name': 'Paclitaxel and Carboplatin', 'type': 'DRUG', 'otherNames': ['TC'], 'description': 'patients get Paclitaxel and Carboplatin according to protocol', 'armGroupLabels': ['Paclitaxel and Carboplatin（TC）']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': '1.8Gy/d, d1-5/week, 34Fx', 'armGroupLabels': ['Paclitaxel and Carboplatin（TC）', 'Paclitaxel and Cisplatin (TP)', 'Paclitaxel and Fluorouracil (TF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Kuaile Zhao, MD', 'role': 'STUDY_CHAIR', 'affiliation': '+86 18017312534'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Huadong Hospital', 'class': 'OTHER'}, {'name': "Wuxi No. 4 People's Hospital", 'class': 'OTHER'}, {'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Jiangxi Provincial Cancer Hospital', 'class': 'OTHER'}, {'name': 'Shanxi Province Cancer Hospital', 'class': 'OTHER'}, {'name': 'Gansu Cancer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kuai Le Zhao, MD', 'investigatorAffiliation': 'Fudan University'}}}}