{"registry": "ISRCTN", "registryId": "ISRCTN34802808", "source": "https://www.isrctn.com/ISRCTN34802808", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN34802808/format/default", "fetchedAt": "2026-10-07T17:00:24.431375Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial", "scientificTitle": "Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial", "acronym": "CONKO-001", "hypothesis": "To test the hypothesis that adjuvant chemotherapy with gemcitabine administered after complete resection of pancreatic cancer improves disease-free survival (DFS) by six months or more.", "primaryOutcome": "Disease-free survival (DFS)", "secondaryOutcome": "1. Overall survival (OS) \n2. Toxicity\n3. Quality of life", "intervention": "\n\tPatients were randomised, with stratification for resection, T and nodal status, to receive adjuvant chemotherapy with six cycles of gemcitabine day one, eight and 15 every four weeks (Arm A) or observation (Arm B).\n\tDrug\n\tPhase III\n\tGemcitabine\n      ", "condition": "\n\tPancreatic cancer\n\tCancer\n\tMalignant neoplasm of pancreas\n      ", "studyDesign": "Open multicentre randomised controlled phase III trial", "overallEndDate": "2004-12-31T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2019-07-02T11:10:35.648Z", "eligibility": {"inclusion": "1. Histologically proven resected pancreatic carcinoma\n2. Standard operation\n3. No measurable disease\n4. No prior chemo- or radiotherapy\n5. No active infection\n6. Karnofsky performance status minimum 50%\n7. Adequate haematologic, renal and hepatic function\n8. Cancer antigen 19-9 (CA 19-9), carcinoembryonic antigen (CEA) less than 2.5 x upper limit of normal (ULN)\n9. Start with adjuvant therapy within six weeks after resection\n10. Written informed consent", "exclusion": "1. Active infection\n2. Impaired coagulation (international normalised ratio [INR] and/or activated partial thromboplastin time [aPPT] more than 1.5 x ULN)\n3. Transaminases more than 3 x ULN\n4. Serum creatinine more than 1.5 x ULN\n5. Postoperative tumour markers (CEA/CA19-9) more than 2.5 x ULN\n6. History of another malignant disease other than carcinoma in situ of the uterine cervix or adequately treated basal cell carcinoma of the skin\n7. Pregnant or breastfeeding women", "ageRange": "Not Specified", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "1998-07-01T00:00:00.000Z", "recruitmentEnd": "2004-12-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "368", "totalFinalEnrolment": ""}, "countries": ["Austria", "Germany"], "locations": [{"name": "Augustenburger Platz 1", "city": "Berlin", "state": "", "country": "Germany", "zip": "13344"}], "sponsors": [{"organisation": "Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)", "sponsorType": "Hospital/treatment centre", "rorId": "https://ror.org/001w7jn25"}], "funders": [{"name": "Lilly Deutschland GmbH (Germany)"}]}, "studySha256": "1823ba005edbeba58bae79f141478c5f240183c1a687b1c632747f6c7ba8504e"}