Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT00209651
Status:
UNKNOWN
Last Update Posted:
2007-11-01
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced 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': 'D000077146', 'term': 'Irinotecan'}, {'id': 'C103828', 'term': 'titanium silicide'}, {'id': 'C079198', 'term': 'S 1 (combination)'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-10-31', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective tumor response', 'timeFrame': '1-year'}], 'secondaryOutcomes': [{'measure': 'Response duration, time to progression, overall survival, and safety will also be assessed.', 'timeFrame': '2-years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Irinotecan, S-1, Phase II, colorectal cancer,'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.', 'detailedDescription': 'A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histological diagnosis of colorectal adenocarcinoma.\n2. Measurable or assessable lesions.\n3. Age: 18 \\~ 75 years.\n4. Performance Status (ECOG): 0 \\~ 2.\n5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \\>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.\n6. No history of treatment with CPT-11 or S-1.\n7. No history of radiotherapy to the abdomen.\n8. Oral intake of S-1 is possible.\n9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \\<1.5 mg/dl (but if it is 1.0 \\~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).\n10. Predicted survival for \\>3 months.\n11. Able to give written informed consent\n\nExclusion Criteria:\n\n1. Severe pleural effusion or ascites.\n2. Metastasis to the central nervous system (CNS).\n3. Active gastrointestinal bleeding.\n4. Active infection.\n5. Diarrhea (watery stools).\n6. Uncontrolled ischemic heart disease.\n7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).\n8. Active multiple cancer.\n9. Severe mental disorder.\n10. Pregnancy, possible pregnancy, or breast-feeding.\n11. Flucytosine treatment\n12. Gilbert's syndrome (4).\n13. Judged to be ineligible for this protocol by the attending physician."}, 'identificationModule': {'nctId': 'NCT00209651', 'briefTitle': 'Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hokkaido Gastrointestinal Cancer Study Group'}, 'officialTitle': 'Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302', 'orgStudyIdInfo': {'id': 'HGCSG0302'}, 'secondaryIdInfos': [{'id': 'IRIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Irinotecan and S-1', 'interventionNames': ['Drug: Campto, Topotesin', 'Drug: TS-1']}], 'interventions': [{'name': 'Campto, Topotesin', 'type': 'DRUG', 'otherNames': ['irinotecan'], 'description': 'q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.', 'armGroupLabels': ['1']}, {'name': 'TS-1', 'type': 'DRUG', 'otherNames': ['S-1'], 'description': '80 mg/m2, PO (oral) on day 1\\~14 of each 28 day cycle.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '060-8638', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}], 'overallOfficials': [{'name': 'Yoshito Komatsu, MD.PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hokkaido Gastrointestinal Cancer Study Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hokkaido Gastrointestinal Cancer Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hokkaido University Hospital', 'class': 'OTHER'}]}}}