Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-05 @ 3:38 PM
Study NCT ID:
NCT02558868
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2015-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '1 years'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '1 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24982456', 'type': 'RESULT', 'citation': 'Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed advanced pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study.\n* Additional inclusion criteria were age 18 years or older\n* Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)\n* Karnofsky performance status (KPS) of at least 70%\n* -Adequate renal function, adequate hepatic function, adequate bone marrow function\n\nExclusion Criteria:\n\n* The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain\n* Hypersensitivity to study drugs\n* Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)\n* National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy\n* Prior or concurrent malignancy (other than pancreatic cancer)\n* Female, pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT02558868', 'briefTitle': 'Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Advanced Pancreatic Cancer Patients Progressed After First-line Gemcitabine and S-1: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'ZYYYMedOncoPAC02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxaliplatin + Irinotecan', 'description': 'Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w', 'interventionNames': ['Drug: Irinotecan', 'Drug: Oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Irinotecan', 'description': 'Irinotecan：180 mg/m2，iv 120 min，d1 q2w', 'interventionNames': ['Drug: Irinotecan']}], 'interventions': [{'name': 'Irinotecan', 'type': 'DRUG', 'armGroupLabels': ['Irinotecan', 'Oxaliplatin + Irinotecan']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['Oxaliplatin + Irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First affiliated hospital, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Weijia Fang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital,Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Weijia Fang', 'investigatorAffiliation': 'Zhejiang University'}}}}