Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT03961867
Status:
UNKNOWN
Last Update Posted:
2021-06-01
First Post:
2019-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], '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': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': '3 year', 'description': 'The interval from randomization to local recurrence, distant metastasis, death or the last follow-up'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 year', 'description': 'The interval from randomization to death or the last follow-up'}, {'measure': 'Treatment related Adverse Events', 'timeFrame': '1 year', 'description': 'According to CTC version 5'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.\n\nDocetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.\n\nThis trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.', 'detailedDescription': 'In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.\n\nGroup DS:\n\nS-1 is orally administer by BSA (\\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \\>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.\n\nDocetaxel 40mg/m2/3w from the second to the seventh cycles.\n\nGroup SOX:\n\nS-1 is orally administer by BSA (\\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \\>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.\n\nOxaliplatin 130mg/m2/3w from the first to the eight cycles.\n\nThe primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consensus of patients\n* be able to receive oral administration\n* from 18 to 75 years old\n* be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences\n* without other chemotherapy and/or radiation against to the disease\n* normal function of other organs including heart,liver ,kidney and so on\n* Eastern Cooperative Oncology Group performance status:0\\~2\n\nExclusion Criteria:\n\n* history of other malignancy\n* allergic reaction to S-1 or oxaliplatin of docetaxel\n* be enrolling in other clinical trials\n* abnormal GI tract function\n* dysfunction of other organs\n* female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy\n* other situation to be judged not adaptive to the study by investigators'}, 'identificationModule': {'nctId': 'NCT03961867', 'briefTitle': 'Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SAHMO203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DS', 'description': 'D2 resection -- S1 \\* 1 cycle + DS \\* 6 cycles + S1 \\* 9 cycles', 'interventionNames': ['Drug: Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOX', 'description': 'D2 resection -- SOX \\* 8 cycles + S1 \\* 8 cycles', 'interventionNames': ['Drug: Oxaliplatin']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['S-1'], 'description': 'S-1 (BSA \\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \\>1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.\n\nDocetaxel 40mg/m2/3w from the second to the seventh cycles.', 'armGroupLabels': ['DS']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['S-1'], 'description': 'S-1 (BSA \\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \\>1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.\n\nOxaliplatin 130mg/m2/3w from the first to the eight cycles.', 'armGroupLabels': ['SOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Xiao, MD', 'role': 'CONTACT', 'email': 'xiao_jian@139.com'}], 'facility': 'Sixth Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shanshan Li, MD', 'role': 'CONTACT', 'email': 'lishsh89@163.com', 'phone': '86-20-38285497'}], 'overallOfficials': [{'name': 'Jian Xiao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jian Xiao', 'investigatorAffiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}}}}