Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT00660894
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2008-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005641', 'term': 'Tegafur'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'C103828', 'term': 'titanium silicide'}], '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'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2008-04-16', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}, {'measure': 'Adverse event'}, {'measure': 'Pharmaco-economics'}, {'measure': 'Identification of predictive markers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the colon', 'stage III colon cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '30425843', 'type': 'DERIVED', 'citation': 'Kusumoto T, Ishiguro M, Nakatani E, Yoshida M, Inoue T, Nakamoto Y, Shiomi A, Takagane A, Sunami E, Shinozaki H, Takii Y, Maeda A, Ojima H, Hashida H, Mukaiya M, Yokoyama T, Nakamura M, Munemoto Y, Sugihara K. Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer. ESMO Open. 2018 Oct 7;3(6):e000428. doi: 10.1136/esmoopen-2018-000428. eCollection 2018.'}, {'pmid': '24942277', 'type': 'DERIVED', 'citation': 'Yoshida M, Ishiguro M, Ikejiri K, Mochizuki I, Nakamoto Y, Kinugasa Y, Takagane A, Endo T, Shinozaki H, Takii Y, Mochizuki H, Kotake K, Kameoka S, Takahashi K, Watanabe T, Watanabe M, Boku N, Tomita N, Nakatani E, Sugihara K; ACTS-CC study group. S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial). Ann Oncol. 2014 Sep;25(9):1743-1749. doi: 10.1093/annonc/mdu232. Epub 2014 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer.\n\nPURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the disease-free survival of patients with stage III colon cancer treated with S-1 or tegafur-uracil and leucovorin after curative surgery .\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days 1-21. The treatment repeats 5 times every 5 weeks.\n* Arm II: Patients receive oral S-1 twice daily on days 1-28. The treatment repeats 4 times every 6 weeks.\n\nBiological samples are collected for gene expression analysis for identification of predictive markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of colon\n\n * Stage III (T1-4, N1-3, M0) disease\n* Has undergone surgical resection of the tumor within the past 8 weeks\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* Able to take medications orally\n* WBC ≥ 3,500/mm³ and \\< 12,000/mm³\n* ANC ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin ≥ 9.0 g/dL\n* Total bilirubin ≤ 2.0 mg/dL\n* AST/ALT ≤ 100 IU/L\n* Creatinine ≤ 1.2 mg/dL\n* No other active malignancies\n* Must have none of the following comorbidities:\n\n * Severe postoperative complications\n * Uncontrollable diabetes mellitus\n * Uncontrollable hypertension\n * Myocardial infraction within 6 months\n * Unstable angina pectoris\n * Hepatocirrhosis\n * Interstitial pneumonia, pulmonary fibrosis, or severe emphysema\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy for colon cancer\n* No concurrent radiotherapy\n* No concurrent biological response modifiers'}, 'identificationModule': {'nctId': 'NCT00660894', 'briefTitle': 'Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan'}, 'officialTitle': 'Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression', 'orgStudyIdInfo': {'id': 'CDR0000593164'}, 'secondaryIdInfos': [{'id': 'TMDU-TRICC0706', 'type': 'OTHER', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tegafur-gimeracil-oteracil potassium', 'description': 'Patients receive tegafur-gimeracil-oteracil potassium(S-1) orally twice daily for 28 days with a subsequent pause of 14 days. This repeats 4 times every 6 weeks.', 'interventionNames': ['Drug: tegafur-gimeracil-oteracil potassium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tegafur-uracil and folinate calcium', 'description': 'Patients receive tegafur-uracil(UFT) plus folinate calcium(leucovorin) orally every 8 hours for 21 days with a subsequent pause of 7 days. This repeats 5 times every 5 weeks.', 'interventionNames': ['Drug: folinate calcium', 'Drug: tegafur-uracil']}], 'interventions': [{'name': 'folinate calcium', 'type': 'DRUG', 'otherNames': ['Leucovorin, leucovorin'], 'armGroupLabels': ['tegafur-uracil and folinate calcium']}, {'name': 'tegafur-uracil', 'type': 'DRUG', 'otherNames': ['UFT'], 'armGroupLabels': ['tegafur-uracil and folinate calcium']}, {'name': 'tegafur-gimeracil-oteracil potassium', 'type': 'DRUG', 'otherNames': ['S-1, TS-1'], 'armGroupLabels': ['tegafur-gimeracil-oteracil potassium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113-8519', 'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Kenichi Sugihara, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tokyo Medical and Dental University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}