Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT02570893
Status:
UNKNOWN
Last Update Posted:
2015-10-07
First Post:
2015-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in 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': 'D018714', 'term': 'Radiotherapy, Adjuvant'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'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': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 366}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2015-10-03', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall survival', 'timeFrame': '3 years', 'description': 'To evaluate the 3 years overall survival of two groups.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 years', 'description': 'To evaluate the 3 years disease-free survival of two groups.'}, {'measure': 'Adverse Events', 'timeFrame': '1 year', 'description': 'Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0'}, {'measure': 'Scores of Quality of life', 'timeFrame': '1 year', 'description': 'Assess the quality of life based on FACT-E'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.', 'detailedDescription': 'Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;\n2. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);\n3. The expectation of life is more than 6 months;\n4. Age: 18\\~70 years old;\n5. Normal hemodynamic indices before the recruitment (including white blood cell count\\>4.0×109/L, neutrophil count\\>1.5×109/L, platelet count \\>100×109/L, hemoglobin≥90g/l, normal liver/kidney function);\n6. ECOG (Eastern Cooperative Oncology Group) : 0-1;\n7. Able to understand this study and have signed informed consent.\n\nExclusion Criteria:\n\n1. Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;\n2. Known or suspected of allergy to paclitaxel or carboplatin;\n3. Female in pregnancy or lactating;\n4. With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;\n5. Patients with peripheral neuropathy(CTC grade≥2);\n6. With other malignant tumors before the recruitment.\n7. The researchers consider that the patient is not appropriate to enroll the study;\n8. The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on."}, 'identificationModule': {'nctId': 'NCT02570893', 'briefTitle': 'A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'ZTOG-1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'adjuvant chemoradiotherapy', 'description': 'Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.', 'interventionNames': ['Radiation: Adjuvant radiotherapy', 'Drug: Paclitaxel and carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'adjuvant radiotherapy', 'description': 'Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.', 'interventionNames': ['Radiation: Adjuvant radiotherapy']}], 'interventions': [{'name': 'Adjuvant radiotherapy', 'type': 'RADIATION', 'description': 'Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.', 'armGroupLabels': ['adjuvant chemoradiotherapy']}, {'name': 'Adjuvant radiotherapy', 'type': 'RADIATION', 'description': 'adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.', 'armGroupLabels': ['adjuvant radiotherapy']}, {'name': 'Paclitaxel and carboplatin', 'type': 'DRUG', 'armGroupLabels': ['adjuvant chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weimin Mao, MD.', 'role': 'CONTACT', 'email': 'maowmzj1218@163.com', 'phone': '+86-571-88122032'}, {'name': 'Yaping Xu, MD.', 'role': 'CONTACT', 'email': 'xuyaping1207@gmail.com', 'phone': '+86-571-88122082'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Weimin Mao, MD.', 'role': 'CONTACT', 'email': 'maowmzj1218@163.com', 'phone': '+86-571-88122032'}, {'name': 'Yaping Xu, MD.', 'role': 'CONTACT', 'email': 'xuyaping1207@gmail.com', 'phone': '+86-571-88122082'}], 'overallOfficials': [{'name': 'Weimin Mao, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}