{"registry": "ISRCTN", "registryId": "ISRCTN96397434", "source": "https://www.isrctn.com/ISRCTN96397434", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN96397434/format/default", "fetchedAt": "2026-10-07T17:00:55.953822Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A trial comparing gemcitabine alone with gemcitabine and capecitabine together after surgery to remove cancer of the pancreas", "scientificTitle": "European Study Group for Pancreatic Cancer (ESPAC) - Trial 4: combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer", "acronym": "ESPAC-4", "hypothesis": "To investigate if combination chemotherapy (gemcitabine and capecitabine), when used as adjuvant therapy in patients following resection for pancreatic adenocarcinoma, improves survival over adjuvant therapy using gemcitabine alone.", "primaryOutcome": "Current primary outcome measure as of 31/05/2011:\nLength of survival. Duration of follow-up: 60 months from randomisation.\n\nPrevious primary outcome measure:\nLength of survival. Duration of follow-up: 60 months from the date of surgery.", "secondaryOutcome": "1. Toxicity. Duration of follow-up: 60 months from the date of surgery.\n2. Quality of life, assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaires (EORTC C-30 QLQ) at baseline, 3, 6, 12, 16 and 24 months and annually thereafter up to 60 months\n3. Two-year survival\n4. Five-year survival\n5. Relapse free survival (RFS). Duration of follow-up: 60 months from the date of surgery.", "intervention": "\n\tGemcitabine and capecitabine versus gemcitabine alone\n\nGemcitabine administration:\n1,000 mg/m^2 gemcitabine must be given as an intravenous infusion, the lyophilised powder being diluted in normal saline, over 30 minutes unless haematological toxicity occurs requiring dose adjustment. Administer on day 1, 8 and 15 (one cycle) for six cycles i.e. 24 weeks.  \n\nCapecitabine administration:\n830 mg/m^2 capecitabine must be administered orally morning and evening daily (total daily dose of 1,660 mg/m^2) unless toxicity occurs requiring dose adjustment. The gemcitabine and capecitabine combination schedule used in this study originates from phase I data published by Schilsky et al. In this study the maximum tolerated dose was defined at gemcitabine 1 g/m^2 on days 1, 8 and 15, and capecitabine 1,660 mg/m^2/day given on days 1 - 21 every 28 days.\n\tDrug\n\tPhase III\n\tGemcitabine, capecitabine\n      ", "condition": "\n\tResectable pancreatic cancer\n\tCancer\n\tPancreatic cancer\n      ", "studyDesign": "Phase III international randomised controlled trial", "overallEndDate": "2017-10-31T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00058201", "lastUpdated": "2025-03-31T13:10:54.206270527Z", "eligibility": {"inclusion": "1. Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection)\n2. Completion of all pre-operative investigations\n3. Histological confirmation of the primary diagnosis\n4. Histological examination of all resection margins\n5. No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs - CT scan within 3 months prior to randomisation\n6. A World Health Organization performance status less than 2\n7. Fully recovered from the operation and fit to take part in the trial\n8. Able to attend for administration of the adjuvant therapy\n9. Able to attend for long-term follow-up\n10. Life expectancy greater than 3 months\n11. No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix)\n12. No serious medical or psychological condition precluding adjuvant treatment\n13. Fully informed written consent given", "exclusion": "1. Use of neo-adjuvant chemotherapy or other concomitant chemotherapy\n2. Patients with pancreatic lymphoma\n3. Macroscopically remaining tumour (R2 resection)\n4. Patients with Tumor-Node-Metastasis (TNM) Stage IVb disease\n5. Patients younger than 18 years\n6. Pregnancy\n7. New York Heart Association Classification Grade III or IV\n8. Previous chemotherapy\n9. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom\n10. Patients with known malabsorption", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2008-10-13T00:00:00.000Z", "recruitmentEnd": "2017-10-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "722", "totalFinalEnrolment": "730"}, "countries": ["United Kingdom", "France", "Germany", "Sweden"], "locations": [{"name": "106 hospitals", "city": "", "state": "", "country": "United Kingdom", "zip": "-"}], "sponsors": [{"organisation": "University of Liverpool and the Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)", "sponsorType": "University/education", "rorId": "https://ror.org/009sa0g06"}], "funders": [{"name": "Cancer Research UK (CRUK) (UK) - funding the central co-ordination of the trial (the Liverpool Cancer Trials Unit) (grant ref: C245/A8968)"}, {"name": "National Cancer Research Network (NCRN) nurse support at UK sites. Non-UK sites will be required to secure their own funding for participating in the trial."}]}, "studySha256": "5fd48596f2927a12272837699abf3c26b6646ddb1653ebb0e0bb59c8824c2297"}