Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 2:15 PM
Study NCT ID:
NCT00891332
Status:
COMPLETED
Last Update Posted:
2012-01-18
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-16', 'studyFirstSubmitDate': '2009-04-30', 'studyFirstSubmitQcDate': '2009-04-30', 'lastUpdatePostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'During chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'During chemotherapy'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Until progression'}, {'measure': 'Disease control rate(DCR)', 'timeFrame': 'During chemotherapy'}, {'measure': 'Time to treatment failure (TTF)', 'timeFrame': 'Until progression'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Over two years from registration'}, {'measure': 'Feasibility', 'timeFrame': 'During chemotherapy'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'During chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proved adenocarcinoma\n* Unresectable and recurrent colorectal cancer\n* Age20 ≤ at enrollment\n* Performance status 0 or 1 (ECOG)\n* No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded\n* Adequate hematologic, hepatic and renal functions\n* At least one measurable lesion by RECIST criteria\n\nExclusion Criteria:\n\n* Serious drug hypersensitivity\n* Pregnant or nursing\n* Bleeding from gastrointestinal tract\n* Diarrhea\n* Simultaneously active double cancer\n* Serious illness or medical condition\n* Brain metastasis'}, 'identificationModule': {'nctId': 'NCT00891332', 'briefTitle': 'Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Taiho10020400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'S-1 plus LV', 'interventionNames': ['Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)']}], 'interventions': [{'name': 'S-1 plus LV (The combination therapy of S-1 and Leucovorin)', 'type': 'DRUG', 'description': 'S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Dong Feng Dong road,Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center, Division of Oncology', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200032', 'city': 'Dong An Road, Shanghai', 'country': 'China', 'facility': 'Shanghai Fudan University Cancer Hospital, Division of Oncology', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '100071', 'city': 'East Avenue, Fengtai District, Beijing', 'country': 'China', 'facility': 'PLA 307 Hospital, No.4 Division of Oncology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100036', 'city': 'Fucheng Road, Haidian District, Beijing', 'country': 'China', 'facility': 'Beijing Cancer Hospital, Digestive System Medicine Department', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100021', 'city': 'Panjiayuan Nanli, Chaoyang District, Beijing', 'country': 'China', 'facility': 'Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '860-8556', 'city': '1-1-1, Honjo Kumamoto-city, Kumamoto', 'country': 'Japan', 'facility': 'Graduate School of Medical Sciences Kumamoto University', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}], 'overallOfficials': [{'name': 'Hideo Baba, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Graduate School of Medical Sciences Kumamoto University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}