Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT00320294
Status:
UNKNOWN
Last Update Posted:
2007-03-12
First Post:
2006-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ILF With/Without Cisplatin 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': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-03'}, 'lastUpdateSubmitDate': '2007-03-09', 'studyFirstSubmitDate': '2006-05-01', 'studyFirstSubmitQcDate': '2006-05-02', 'lastUpdatePostDateStruct': {'date': '2007-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate'}, {'measure': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival'}, {'measure': 'Overall survival'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'conditions': ['Stomach Neoplasm']}, 'referencesModule': {'references': [{'pmid': '18083691', 'type': 'DERIVED', 'citation': 'Park SH, Nam E, Park J, Cho EK, Shin DB, Lee JH, Lee WK, Chung M, Lee SI. Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer. Ann Oncol. 2008 Apr;19(4):729-33. doi: 10.1093/annonc/mdm502. Epub 2007 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.', 'detailedDescription': 'Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen \\[Pozzo C, et al. Ann Oncol 2004\\]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven gastric adenocarcinoma\n* Advanced, metastatic or recurrent\n* ECOG performance status 0 to 2\n* No prior chemotherapy\n* Measurable or evaluable indicator lesion(s)\n* Normal marrow, hepatic and renal functions\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Active infection, bleeding or severe comorbidities\n* Pregnant or breastfed women\n* Active CNS metastasis'}, 'identificationModule': {'nctId': 'NCT00320294', 'briefTitle': 'ILF With/Without Cisplatin for Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'GMO-GI-52'}}, 'armsInterventionsModule': {'interventions': [{'name': 'irinotecan', 'type': 'DRUG'}, {'name': 'cisplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '405 760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Se Hoon Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center, Incheon, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}}}}