Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-28 @ 5:30 AM
Study NCT ID:
NCT01198392
Status:
UNKNOWN
Last Update Posted:
2011-07-25
First Post:
2010-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of S-1 Plus Cisplatin in Gastric Cancer
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': 'C000711476', 'term': 'S-1 plus cisplatin'}, {'id': 'D005641', 'term': 'Tegafur'}, {'id': 'C104201', 'term': 'gimeracil'}, {'id': 'C489337', 'term': 'potassium oxonate'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2010-09-01', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': 'The time from randomization until objective tumor progression or death'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric cancer'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '26439700', 'type': 'DERIVED', 'citation': 'Li YH, Qiu MZ, Xu JM, Sun GP, Lu HS, Liu YP, Zhong MZ, Zhang HL, Yu SY, Li W, Hu XH, Wang JJ, Cheng Y, Zhou JT, Guo ZQ, Guan ZG, Xu RH. S-1 plus cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: a pilot study. Oncotarget. 2015 Oct 27;6(33):35107-15. doi: 10.18632/oncotarget.5959.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.', 'detailedDescription': 'This is a randomized, controlled, open-label,multicenter study. Patients are randomized to one of two treatment arms : S-1 plus cisplatin and 5-FU plus cisplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.\n* Male or female.\n* Age 18 -75.\n* Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).\n* Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)\n* ECOG Performance status 0, 1 or 2\n* Haematological, Biochemical and Organ Function: Neutrophil count \\>2.0 × 10 9/L, platelet count \\> 100 ×10 9/L. Serum bilirubin\\< 1.5 × upper limit of normal (ULN); or, AST or ALT \\< 2.5 × ULN (or \\< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\\< 2.5 × ULN (or \\> 5 × ULN in patients with liver metastases,Creatinine clearance \\> 60 mL/min.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* prior adjuvant/neoadjuvant therapy more than two regiments.\n* Received any investigational drug treatment within 30 days of start of study treatment.\n* Patients with active gastrointestinal bleeding.\n* Neurological toxicity ≥ grade 2 NCI-CTCAE.\n* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.\n* History or clinical evidence of brain metastases.\n* Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.\n* Pregnancy women.\n* Subjects with reproductive potential not willing to use an effective method of contraception.\n* Patients with known active infection with HIV.\n* Known hypersensitivity to any of the study drugs.'}, 'identificationModule': {'nctId': 'NCT01198392', 'briefTitle': 'Trial of S-1 Plus Cisplatin in Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': '2005L02859'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1 plus cisplatin', 'description': 'S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks.Number of Cycles: until progression or unacceptable toxicity develops.', 'interventionNames': ['Drug: s-1 plus cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5-Fu plus cisplatin', 'description': '5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks.Number of Cycles: until progression or unacceptable toxicity develops.', 'interventionNames': ['Drug: 5-Fu plus cisplatin']}], 'interventions': [{'name': 's-1 plus cisplatin', 'type': 'DRUG', 'otherNames': ['Tegafur,Gimeracil and Oteracil Potassium Capsules'], 'description': 'S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks. Number of Cycles: until progression or unacceptable toxicity develops.', 'armGroupLabels': ['S-1 plus cisplatin']}, {'name': '5-Fu plus cisplatin', 'type': 'DRUG', 'otherNames': ['5-fluoroura'], 'description': '5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks.\n\nNumber of Cycles: until progression or unacceptable toxicity develops.', 'armGroupLabels': ['5-Fu plus cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Gangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guan Zhongzhen, Professor', 'role': 'CONTACT', 'email': 'guanzhzh@sysucc.org.cn', 'phone': '862087343565'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Guan Zhongzhen, Professor', 'role': 'CONTACT', 'email': 'guanzhzh@sysucc.org.cn', 'phone': '862087343565'}, {'name': 'Xu Ruihua, Professor', 'role': 'CONTACT', 'email': 'xurh@sysucc.org.cn', 'phone': '862087343228'}], 'overallOfficials': [{'name': 'RUIHUA XU, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zhongzhen Guan ,Ruihua Xu', 'oldOrganization': 'Sun Yat-sen University Cancer Center'}}}}