Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-02 @ 1:36 PM
Study NCT ID:
NCT00343668
Status:
UNKNOWN
Last Update Posted:
2010-05-26
First Post:
2006-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-1 and Irinotecan Combination Chemotherapy 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': 'D000077146', 'term': 'Irinotecan'}], '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': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2006-06-22', 'studyFirstSubmitQcDate': '2006-06-22', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': 'best response'}], 'secondaryOutcomes': [{'measure': 'treatment-related toxicities', 'timeFrame': 'during treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['advanced gastric cancer', 'First-line therapy', 'S-1', 'irinotecan'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The primary goal of this phase II trial is to evaluate the response rate of combination chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven unresectable adenocarcinoma of stomach\n* With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)\n* Age 18 to 70 years old\n* Estimated life expectancy of more than 3 months\n* ECOG performance status of 2 or lower\n* Adequate bone marrow function(absolute neutrophil count \\[ANC\\] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL)\n* Adequate kidney function (serum creatinine \\< 1.5 mg/dL)\n* Adequate liver function (serum total bilirubin \\< 2 times the upper normal limit (UNL); serum transaminases levels \\<3 times \\[\\<5 times for patients with liver metastasis\\] UNL)\n* No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)\n* No prior radiation therapy for at least 4 weeks before enrollment in the study\n\nExclusion Criteria:\n\n* Other tumor type than adenocarcinoma\n* Central nervous system (CNS) metastases or prior radiation for CNS metastases\n* Gastric outlet obstruction or intestinal obstruction\n* Evidence of gastrointestinal bleeding\n* The patient has bony lesions as the sole evaluable disease.\n* Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri\n* Pregnant or lactating women, women of childbearing potential not employing adequate contraception\n* Other serious illness or medical conditions\n\n * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry\n * History of significant neurologic or psychiatric disorders including dementia or seizures\n * Active uncontrolled infection\n * Other serious underlying medical conditions which could impair the ability of the patient to participate in the study\n* Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy\n* concomitant drug medication; The following drugs cause drug interaction with S-1.\n\n i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -\\> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1'}, 'identificationModule': {'nctId': 'NCT00343668', 'briefTitle': 'S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Korean Cancer Study Group'}, 'officialTitle': 'A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy', 'orgStudyIdInfo': {'id': 'KCSG-ST05-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'S-1, irinotecan', 'type': 'DRUG', 'description': 'S-1, 40 mg/m2 PO twice daily, days 1-14 irinotecan, 150 mg/m2 IV, day 1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '519-809', 'city': 'Hwasun-gun', 'state': 'Jeolanam-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Hee Cho, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'sh115@chollian.net', 'phone': '+82-61-379-7633'}, {'name': 'Sang Hee Cho, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chonnam National University Hwasun Hospital'}, {'zip': '561-712', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun Kee Song, M.D.', 'role': 'CONTACT', 'email': 'eksong@chonbuk.ac.kr', 'phone': '+82-63-250-1245'}, {'name': 'Eun Kee Song, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Inchon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Moon Hee Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'moonhlmd@inha.ac.kr', 'phone': '+82-32-890-2583'}, {'name': 'Moon Hee Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inha University hospital', 'geoPoint': {'lat': 35.55479, 'lon': 126.6251}}, {'zip': '110-746', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Sei Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'llssss.lee@samsung.com', 'phone': '+82-2-2001-2084'}, {'name': 'Seung Sei Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Suk Joong Oh, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kwon Choi, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Cheol Chung, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'unchung8@yumc.yonsei.ac.kr', 'phone': '+82-2-2228-8132'}, {'name': 'Hyun Cheol Chung, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sun Young Rha, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hei-Cheul Jeung, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yonsei Cancer Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-791', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong-Seog Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'seog@e-bohun.or.kr', 'phone': '+82-2-2225-1319'}, {'name': 'Bong-Seog Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul Veterans Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-706', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Baek-Yeol Ryoo, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ryooby@kcch.re.kr', 'phone': '+82-2-970-1208'}, {'name': 'Baek-Yeol Ryoo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sung Hyun Yang, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hye Jin Kang, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Im Il Nah, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Korea Institute of radiological and Medical Sciences', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Baek-Yeol Ryoo, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ryooby@kcch.re.kr', 'phone': '+82-2-970-1208'}, {'name': 'Hye Jin Kang, M.D.', 'role': 'CONTACT', 'email': 'hyejin@kcch.re.kr', 'phone': '+82-2-970-1289'}], 'overallOfficials': [{'name': 'Baek-Yeol Ryoo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea Institute of Radiological and Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean Cancer Study Group', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Baek-Yeol Ryoo', 'oldOrganization': 'Korea Cancer Center Hospital'}}}}