Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-25 @ 12:57 AM
Study NCT ID:
NCT02913066
Status:
UNKNOWN
Last Update Posted:
2017-06-16
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
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': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Remission Rate (CR)', 'timeFrame': 'Three months after radiotherapy finished', 'description': 'Complete response rate of primary tumor which will be measured by endoscopy and computer tomography'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Two years after adjuvant chemotherapy finished', 'description': 'The time from treatment completion to patient death'}, {'measure': 'Progression-Free-Survival (PFS)', 'timeFrame': 'Two years after adjuvant chemotherapy finished', 'description': 'The time from treatment completion to disease progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '32864805', 'type': 'DERIVED', 'citation': 'Zhao Z, Wen Y, Liao D, Miao J, Gui Y, Cai H, Chen Y, Wei M, Jia Q, Tian H, Sun M, Zhang Y, Feng G, Du X. Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1900-e1908. doi: 10.1634/theoncologist.2020-0808. Epub 2020 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:\n\nExperimental group: radiotherapy combined with S-1 chemotherapy.\n\nControl group: radiotherapy combined with S-1 chemotherapy and cisplatin.', 'detailedDescription': 'Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:\n\nExperimental group: radiotherapy combined with S-1 chemotherapy;\n\ncontrol group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 \\~ 42 days, plus cisplatin first 1\\~ 4 days and 29 \\~ 33 days. Using IMRT radiotherapy.\n\nTwo weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\\~ 14 days, or S-1 70 mg/m2 1\\~ 14 days, plus cisplatin 25mg/m2 1\\~ 4 days, 21 days for a cycle.\n\nPrimary Outcome Measure is complete remission rate.\n\nSecondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histology or cytology confirmed esophageal squamous cell carcinoma.\n2. There are measurable lesions in the RECIST standard.\n3. American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a\\~ IV B period.\n4. Age younger than 75 years old.\n5. Eastern Cooperative Oncology Group physical status score was 0 \\~ 1.\n6. No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion.\n7. Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before.\n8. Serum hemoglobin is\\<100g/L, platelet\\>100 \\* 109/L,Absolute neutrophil count\\>1.5 \\* 109/L.\n9. Cr≤1.25 upper normal limit or CCr≥60 mL/min.\n10. Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit.\n11. A history of interstitial pneumonia and interstitial pneumonia.\n12. FEV1\\>0.8 liters.\n13. Patients or family members signed a formal informed consent.\n\nExclusion Criteria:\n\n1. Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.\n2. Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.\n3. Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.\n4. Patients with distant metastases.\n5. There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.\n6. Can't understand the test requirements, or patients may not comply with the requirements of the test.\n7. There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years.\n8. An allergic reaction known to have 3 or 4 levels of any treatment.\n9. Had participated in other clinical trials in the past 30 days.\n10. The researchers believe that some of the obvious diseases that should be excluded from this study are excluded."}, 'identificationModule': {'nctId': 'NCT02913066', 'briefTitle': 'S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Mianyang Central Hospital'}, 'officialTitle': 'Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'XDu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single drug', 'description': 'S-1 concurrent Radiotherapy', 'interventionNames': ['Other: S-1 concurrent radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double drug', 'description': 'S-1 plus cisplatin concurrent Radiotherapy', 'interventionNames': ['Other: S-1 plus Cisplatin concurrent radiotherapy']}], 'interventions': [{'name': 'S-1 concurrent radiotherapy', 'type': 'OTHER', 'description': 'Radiotherapy 60\\~66 Gray/28\\~33 times (50.4\\~60 Gray /28\\~33 planning target volume times, 60\\~66 Gray/28\\~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1\\~ 14 days, 21 days for a cycle.', 'armGroupLabels': ['Single drug']}, {'name': 'S-1 plus Cisplatin concurrent radiotherapy', 'type': 'OTHER', 'description': 'Radiotherapy 60\\~66 Gray/28\\~33 times (50.4\\~60 Gray /28\\~30 planning target volume times, Gross tumor volume of primary tumor60\\~66 Gray/28\\~33), synchronous chemotherapy S-1 70 mg/m2 1\\~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1\\~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\\~ 14 days, plus cisplatin 25mg/m2 1\\~ 4 days, 21 days for a cycle.', 'armGroupLabels': ['Double drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '621000', 'city': 'Mianyang', 'state': 'Sichaung', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xaiobo Du, MD', 'role': 'CONTACT', 'email': 'duxiaobo2005@126.com', 'phone': '+86 08162230478'}], 'facility': 'Xiaobo du', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}], 'centralContacts': [{'name': 'Bo Du X, Doctor', 'role': 'CONTACT', 'email': 'duxiaobo2005@126.com', 'phone': '+8613550822229'}, {'name': 'Xue W Y, Student', 'role': 'CONTACT', 'email': '532995900@qq.com', 'phone': '+8615181958867'}], 'overallOfficials': [{'name': 'Bo Du X, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mianyang Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mianyang Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaobo Du', 'investigatorAffiliation': 'Mianyang Central Hospital'}}}}