Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-31 @ 10:04 PM
Study NCT ID:
NCT01090505
Status:
UNKNOWN
Last Update Posted:
2010-03-22
First Post:
2010-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally 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': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-19', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-19', 'lastUpdatePostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'response rate', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. DISEASE CHARACTERISTICS:\n\n Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)\n2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy\n3. Age:20 to 75\n4. Performance status:ECOG 0-2\n5. Life expectancy:Not specified\n6. Hematopoietic:WBC 4,000-12,000/mm\\^3；Granulocyte count ≥ 2,000/mm\\^3；Platelet count ≥ 100,000/mm\\^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL\n7. Adequate organ function\n8. Able to swallow oral medication\n9. Written informed consent\n\nExclusion Criteria:\n\n1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ\n2. Pregnant or breast-feeding women\n3. Severe mental disease\n4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin\n5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease\n6. Myocardial infarction within six disease-free months'}, 'identificationModule': {'nctId': 'NCT01090505', 'briefTitle': 'Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced', 'orgStudyIdInfo': {'id': 'GC-ChinaPLAGH-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug:S-1:80mg/m2;oxaliplatin 130mg/m2', 'description': 'Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy', 'interventionNames': ['Drug: Drug: S-1 and oxaliplatin']}, {'type': 'NO_INTERVENTION', 'label': 'surgery', 'description': 'Procedure/Surgery: Gastrectomy with D2 dissection', 'interventionNames': ['Drug: Drug: S-1 and oxaliplatin']}], 'interventions': [{'name': 'Drug: S-1 and oxaliplatin', 'type': 'DRUG', 'otherNames': ['S-1:Taiho', 'Oxaliplatin：sanofi-aventis'], 'description': 'Drug:S-1:80mg/m2;oxaliplatin 130mg/m2', 'armGroupLabels': ['Drug:S-1:80mg/m2;oxaliplatin 130mg/m2', 'surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fu xing road 28#', 'role': 'CONTACT', 'phone': '86-10-66938328'}], 'facility': 'China PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'L Chen, MD', 'role': 'CONTACT', 'email': 'litbj301@sina.com', 'phone': '86-10-66938028'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'L Chen', 'oldOrganization': 'Chinese PLA General Hospital'}}}}