Malignant neoplasm of pancreas, locally advanced pancreas cancer Cancer Malignant neoplasm of pancreas, locally advanced pancreas cancer
Conditions
Interventions
Patients will be recruited to the study following screening and consent, where they will then have baseline assessments in order to ensure suitability and their health state prior to treatment.
All
Sponsors
Royal Free London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide informed consent 2. Aged =18 years 3. Locally advanced pancreatic cancer anywhere in the pancreas 3. Tissue confirmation of pancreatic adenocarcinoma by biopsy or cytology/pathology 4. Cancer not amenable to surgical resection (following pancreas surgeon/multidisciplinary team review) 5. Completed systemic chemotherapy with FOLFIRINOX (standard or modified ). This must be the only regimen of chemotherapy the patient has had since diagnosis. 6. Considered amenable to irreversible electroporation (IRE) therapy by pancreas interventional radiologist 7. WHO Performance status 0 or 1 8. Maximum cancer diameter 3.5 cm at the time of IRE treatment 9. Considered fit for general anaesthetic following pre-assessment.
Exclusion criteria
Exclusion criteria: 1. First line chemotherapy other than FOLFIRINOX 2. Concomitant malignancy (except skin and prostate cancers) 3. Metastatic disease including distant (i.e. non-local) nodal metastases 4. Borderline resectable disease 5. Occlusion or >180° involvement of the portal vein (superior mesenteric vein/portal vein) 6. Arterial involvement with <180° of the superior mesenteric artery, celiac axis, or common hepatic artery 7. Untreated gastric outlet or biliary obstruction 8. Co-morbidity precluding general anaesthesia 9. Indwelling electrical devices such as pacemakers and Left Ventricular Assist Devices (LVADs) 10. Chronic Kidney Disease stage 3, 4, or 5 11. History of epilepsy or other neurological diseases 12. Abdominal varices preventing safe access to pancreas cancer 13. Unable to tolerate general anaesthetic with neuromuscular blockade 14. Subjects who are actively bleeding, anticoagulation which cannot be discontinued, coagulopathy defined as an international normalized ratio (INR) of =1.5, or have any one of the following haematology results: 14.1. Haemoglobin <8 g/dl 14.2. Absolute neutrophil count <1500 cells/ml 14.3. Platelet count <50,000.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Ability to recruit patients measured using the following from participant records at screening, randomisation, IRE visit (if allocated), restaging visit, surgery visit, follow up visits, end of treatment, and end of the study: 1.1. Rate of recruitment 1.2. Number of screening failures 1.3. Number of patients that complete the study pathway as per protocol 1.4. Rate of withdrawal from trial, the reasons why, and at which stage | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Practicality and the technical success of IRE measured using the following: 1.1. Mortality rate from patient records at 6 weeks, 3, 6, 9, and 12 months post-randomisation and overall 1.2. Technical success rate (complete local therapy) at the time of IRE procedure and operative CT 1.3. Surgical rate from patient records at surgery visit and follow up visits 1.4. Resection rate (R0/R1) from patient records at restaging visit 1.5. Local or systemic disease progression on follow up rate from patient records, at restaging visit and follow up visits 1.6. Adherence to protocol from patient records at the IRE visit, surgery visit, follow up visits, and end of the study 2. The acceptability of treatment to patients and their clinicians measured using the following: 2.1. Health-related quality of life measured using the EurolQol 5-dimension (EQ-5D) questionnaire at randomisation, 3, 6, 9, and 12 months post-randomisation 2.2. Indicative costs related to health resource use in both treatments (IRE and chemotherapy vs chemotherapy alone) assessed across all timepoints 2.3. Social costs of attending for both the IRE treatment and Standard of Care group (travel, time off work, social support costs) assessed across all timepoints 2.4. Return to normal activity rate within 12 months post-randomisation recorded in the case report form at 12 months follow up visit 2.5. Return to employment rate (in those who work) within 12 months post-randomisation recorded in the case report form at 12 months follow up visit 2.6. Number of work days lost (in those who work) within 12 months post-randomisation recorded in the case report form at 12 months follow up visit 3. Safety of the IRE and chemotherapy measured using serious adverse events recorded following randomisation and adverse events recorded in the case report form at follow up visits | — |
Countries
England, United Kingdom
Contacts
Public ContactKellie Platt
Outcome results
None listed