Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-01 @ 6:01 AM
Study NCT ID:
NCT02813967
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer
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': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-13', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the quality of life', 'timeFrame': '5 years', 'description': 'assessed with the European Organisation for Research and Treatment of Cancer quality-of-life core questionnaire QLQ-C30'}, {'measure': 'the oesophagus-specific quality-of-life', 'timeFrame': '5 years', 'description': 'assessed with the European Organisation for Research and Treatment of Cancer quality-of-life the oesophagus-specific questionnaire QLQ-OES18'}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': '2-year over survival'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '5 years'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Cancer', 'Chemoradiation']}, 'referencesModule': {'references': [{'pmid': '34351356', 'type': 'DERIVED', 'citation': 'Ji Y, Du X, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Li P, Wang J, Xu Y, Zheng X, Chen J, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Fang M, Kong Y, Yu X, Li H, Li R, Shi L, Shen W, Zhu C, Lv J, Huang R, He H, Chen M. Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1459-1466. doi: 10.1001/jamaoncol.2021.2705.'}]}, 'descriptionModule': {'briefSummary': 'This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytologic diagnosis of esophageal carcinoma\n* ECOG performance status 0-1\n* Age:70-85 years\n* Joined the study voluntarily and signed informed consent form\n* Patients must not have received any prior anticancer therapy\n* Stage Ⅰ-ⅣB（AJCC 2009）\n* Target lesions can be measured according to RECIST criteria\n* No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\\<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN\n\nExclusion Criteria:\n\n* Multiple carcinomas of the esophagus,\n* Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,\n* Metastatic disease (M1b),\n* A primary tumor that extended to within 2 cm of the gastroesophageal junction,\n* Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,\n* history of a second malignancy other than nonmelanoma skin cancer'}, 'identificationModule': {'nctId': 'NCT02813967', 'briefTitle': 'S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Prospective, Randomized, Multi-center Phase-III Study', 'orgStudyIdInfo': {'id': 'ZJCH-E-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chemoradiotherapy', 'description': 'Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42', 'interventionNames': ['Radiation: Radiotherapy 54 Gy', 'Drug: S-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiotherapy 60 Gy', 'description': 'Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.', 'interventionNames': ['Radiation: Radiotherapy 60 Gy']}], 'interventions': [{'name': 'Radiotherapy 54 Gy', 'type': 'RADIATION', 'description': 'Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.', 'armGroupLabels': ['chemoradiotherapy']}, {'name': 'Radiotherapy 60 Gy', 'type': 'RADIATION', 'description': 'Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.', 'armGroupLabels': ['Radiotherapy 60 Gy']}, {'name': 'S-1', 'type': 'DRUG', 'description': 'S-1 70mg/m2 was administered on days 1-14 and 29-42.', 'armGroupLabels': ['chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'MING CHEN, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang Cancer Hospital'}, {'name': 'XIANGHUI DU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}, {'name': 'youngling JI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang Cancer Hospital'}, {'name': 'weiguo zhu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Huaian first people's hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}