{"registry": "ISRCTN", "registryId": "ISRCTN89500674", "source": "https://www.isrctn.com/ISRCTN89500674", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN89500674/format/default", "fetchedAt": "2026-10-07T17:00:56.565948Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "ESPAC-5: European Study group for Pancreatic Cancer - Trial 5", "scientificTitle": "ESPAC - 5: European Study Group for Pancreatic Cancer - Trial 5: four arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy", "acronym": "ESPAC-5", "hypothesis": "ESPAC-5: a multi-centre, prospective, randomised, feasibility Phase II trial comparing neoadjuvant therapy to immediate surgical exploration in patients with borderline resectable pancreatic cancer. The aim of this study will be to compare neoadjuvant chemotherapy (GemCap or FOLFIRINOX) or chemoradiotherapy with immediate surgery. All patients who undergo resection will also receive adjuvant chemotherapy as standard.", "primaryOutcome": "1. Recruitment rate\nRecruitment rate will be measured by the proportion of centres that successfully engage in the study and by the overall recruitment. Centres will be classified as successfully engaged if the study has opened in a timely fashion and if they are achieving over 50% of the recruitment and randomisation rate estimated for their centre. The overall recruitment rate will be deemed successful if at least 80% of the centres have fully engaged in the study and the target rate has been achieved (100 patients in 24 months).\n\n2. Resection rate\nAn overall resection rate will be measured using the total number of patients at baseline. A second resection rate will also be measured using only the patients who undergo explorative surgery. R1 and R0 resection margins will be used when measuring the resection rate – R2 resection margins will be excluded.", "secondaryOutcome": "Not provided at time of registration", "intervention": "\n\tIf eligible for the study patients will be randomised onto one of the following arms.  \n\nArm A (control): Surgery. Eligible patients will undergo surgical exploration for resection within two weeks of randomisation. Following recovery from successful resection (up to 12 weeks) patients will undergo standard adjuvant chemotherapy either gemcitabine or 5-fluorouracil for six cycles ie. 24 weeks. If patients do not undergo successful resection then following recovery from surgery, further therapy will be as physician’s choice. Patients will be followed up for 12 months after randomisation.\n\nArm B: GEMCAP. Within two weeks of randomisation, eligible patients will commence neoadjuvant Gemcitabine, 1000mg/m2 iv infusion over 30 mins, once a week for 3 of 4 weeks  and capecitabine 830mg/m2 BD PO for 21 /28d, (one cycle) for 2 cycles i.e. 8 weeks . Four to six weeks after completion chemotherapy patients will undergo staging CT scan. If there has been no progression patients will then undergo surgical exploration within two weeks as for Arm A. \n\nArm C: FOLFIRINOX - Within two weeks of randomisation, eligible patients will commence neoadjuvant Oxaliplatin 85mg/m2, Irinotecan 180mg/m2, Folinic acid 400mg/m2, 5-FU 2400mg/m2 46 hour infusion, repeated every 2 weeks for 4 cycles.  Growth factor support may be administered at the investigator’s discretion. Four to six weeks after completion chemotherapy patients will undergo staging CT scan. If there has been no progression patients will then undergo surgical exploration within two weeks as for Arm A.\n\nArm D: CRT. Within two weeks of randomisation, eligible patients will commence neoadjuvant CRT delivering a total dose of 50.4Gy in 28 daily fractions over 5 1/2 weeks (1.8Gy/#fraction Mon to Fri) with Capecitabine 830mg/m2 BD PO (Mon to Fri) throughout radiotherapy. Centres would be required to choose to use IMRT (preferred) or 3D conformal RT for all their patients. Four to six weeks after completion CRT patients will undergo staging CT scan. If there has been no progression patients will then undergo surgical exploration within two weeks as for Arm A. \n\nPatients will be followed up for 12 months after randomisation.\n\tMixed\n\t\n\t\n      ", "condition": "\n\tTopic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Pancreas\n\tCancer\n\t\n      ", "studyDesign": "Randomised; Interventional; Design type: Process of Care, Screening, Treatment", "overallEndDate": "2021-01-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2026-06-09T10:49:49.991933829Z", "eligibility": {"inclusion": "1. Borderline resectable mass in the pancreatic head as defined by CT criteria\n2. Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants)\n3. Able to undergo biliary drainage using a fully covered self expanding metal stent\n4. Age >= 18 years\n5. WHO performance status 0, 1\n6. Platelets >100 x 10^9/l; WBC > 3 x 10^9/l; neutrophils > 1.5 x 10^9/l\n7. Serum bilirubin =1.5 ULN\n8. Calculated creatinine clearance > 50ml/min\n9. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy.\n10. Written informed consent; Target Gender: Male & Female ; Lower Age Limit 18 years", "exclusion": "1. Distant metastatic disease\n2. History of previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix)\n3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection\n4. Previous chemotherapy or chemoradiotherapy\n5. Pregnancy\n6. WHO performance status 24\n7. New York Heart Association Classification Grade III or IV\n8. Patients with known malabsorption", "ageRange": "Mixed", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2014-08-26T00:00:00.000Z", "recruitmentEnd": "2018-12-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "100", "totalFinalEnrolment": "90"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "Cancer Research UK Liverpool Cancer Trials Unit", "city": "Liverpool", "state": "", "country": "England", "zip": "L69 3GL"}], "sponsors": [{"organisation": "University of Liverpool (UK)", "sponsorType": "University/education", "rorId": "https://ror.org/04xs57h96"}], "funders": [{"name": "Cancer Research UK (UK)", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "8f11153d33ce793963c4c84866cddd5fb270c1f5d813b12cab7838bbcac98c14"}