Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-27 @ 1:07 AM
Study NCT ID:
NCT00202969
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced 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': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D005472', 'term': 'Fluorouracil'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-06', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'every course for first three courses, then every other course'}], 'secondaryOutcomes': [{'measure': 'Safety profile, time to treatment failure', 'timeFrame': 'any time'}]}, 'conditionsModule': {'keywords': ['Stomach cancer'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \\>1), prior gastrectomy, and center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-prior chemotherapy treated advanced gastric adenocarcinoma\n* Age 18 and over\n* Performance status 0, 1, or 2 (ECOG)\n* Life expectancy 3 months\n* Hematopoietic WBC lower limit of normal-12,000/mm\\^3 Absolute granulocyte count ≥ 2,000/mm\\^3 Platelet count ≥ 100,000/mm\\^3 Hemoglobin ≥ 8.0 g/dL\n* Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL\n* Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min\n\nExclusion Criteria:\n\n* Interstitial pneumonia, pulmonary fibrosis\n* Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure\n* Intestinal paralysis, intestinal obstruction, uncontrollable diabetes'}, 'identificationModule': {'nctId': 'NCT00202969', 'briefTitle': 'Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease', 'orgStudyIdInfo': {'id': 'SC101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'S-1', 'interventionNames': ['Drug: S-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'S-1 plus CDDP', 'interventionNames': ['Drug: S-1 plus CDDP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '5-FU plus CDDP', 'interventionNames': ['Drug: 5-FU plus CDDP']}], 'interventions': [{'name': 'S-1', 'type': 'DRUG', 'description': 'S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.', 'armGroupLabels': ['1']}, {'name': 'S-1 plus CDDP', 'type': 'DRUG', 'description': 'S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.', 'armGroupLabels': ['2']}, {'name': '5-FU plus CDDP', 'type': 'DRUG', 'description': '5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'No.52 Fu-Cheng Road, Hai-dian District', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital'}], 'overallOfficials': [{'name': 'Jin Maolin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Taiho Pharmaceutical Co., Ltd.', 'oldOrganization': 'Taiho Pharmaceutical Co., Ltd.'}}}}