Pancreatic cancer Cancer Pancreatic cancer
Conditions
Interventions
Patients will be registered according to their performance status and age (younger patients with better performance status will be registered to receive FOLFOX-A, with older patients with worse perfor
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has provided written informed consent and is registered to the PRECISION PANC master protocol 2. Signed informed consent given for PRIMUS 002 study 3. Age =16 years 4. Resectable or borderline resectable pancreatic cancer as defined by RECIST v1.1 criteria following discussion at the MDT 5. Measurable Disease as per RECIST 1.1 6. Histological or cytologically proven pancreatic ductal adenocarcinome (including variants) 7. Able to undergo biliary drainage using a covered or partially covered self-expanding metal stent if jaundiced 8. ECOG performance status 0 and 1 9. Adequate liver/bone marrow function as defined by: 9.1. Neutrophils = 1.5 x 109/l 9.2. Platelets = 100 x 109/l 9.3. Haemoglobin = 9.0g/dL 9.4. WBC = 3 x 109/l 9.5. Total bilirubin = 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndrome 9.6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (and 60 mL/min 10. Negative serum Human Chorionic Gonadotropin (HCG) test for females with child bearing potential. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential 11. Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see section 8.1.8.1) for the duration of the study and for up to 6 months after the completion of study treatment. 12. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy
Exclusion criteria
Exclusion criteria: 1. Unable to obtain sufficient tissue for NGS analysis 2. Distant metastatic disease 3. History of previous or concurrent malignancy diagnosis (except curatively treated basil cell carcinoma of skin or carcinoma in situ of cervix) 4. Prior chemotherapy or chemoradiotherapy (exceptions may be given case by case by the Chief Investigator (CI), such as methotrexate for rheumatoid arthritis) 5. Known hypersensitivity for any component of any study drug 6. Active infection including Herpes Zoster and chickenpox 7. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months. 8. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection 9. New York Heart Association Classification Grade III or IV 10. Uncontrolled angina/ischaemic heart disease 11. Major surgery within 28 days prior to trial entry 12. Any patients receiving treatment with brivudin, sorivudin and analogues 13. Any patient with severe diarrhoea. 14. Patients with known malabsorption 15. Patients with known or suspected DPD (dihydropyrimidine dehydrogenase) deficiency. 16. Grade = 2 peripheral neuropathy 17. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to progression following FOLFOX-A treatment is assessed through CT scans at baseline, prior to radiotherapy and prior to surgery. Further scans will be performed as per standard of care to progression. 2. Efficacy of proposed biomarkers in predicting disease progression rates in FOLFOX-A arm. Tissue samples will be collected from the patients at baseline (under the Precision Panc Master Protocol), prior to radiotherapy and at surgery/progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Translational research assessment of cloncal evolution and acquired resistance mechanisms due to treatment, Response based on RECIST 1.1 post neo-adjuvant chemotherapy. The patient will have a CT scan at baseline, prior to radiotherapy and prior to surgery. Further scans will be performed as per standard of care to progression. 2. CAP tumour regression grade post surgery, this will be assessed by MDT after surgery 3. R0 rate post surgery, this will be assessed by MDT after surgery 4. Overall survival, this will be assessed at every chemotherapy visit, radiotherapy planning, radiotherapy, surgery and at every follow up visit (6, 9, 12, 18, 24, 36, 48, 60 months post registration) 5. Disease free survival, this will be assessed at every chemotherapy visit, radiotherapy planning, radiotherapy, surgery and at every follow up visit (6, 9, 12, 18, 24, 36, 48, 60 months post registration) 6. Safety and tolerability as assessed by NCI CTC 4.03, this will be assessed at every chemotherapy visit, radiotherapy planning, radiotherapy, surgery and at every follow up visit (6, 9, 12, 18, 24, 36, 48, 60 months post registration) 7. Neurotoxicity as assessed by GOG NTx4, this will be assessed montlhy while on chemotherapy, prior to surgery and at follow-up visits 8. Quality of life as assessed by EORTC QLQ-C30 version 3 and the pancreatic-specific QLQ-PAN26 QOL module, this will be assessed montlhy while on chemotherapy, prior to surgery and at follow-up visits | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSarah Bradley
Outcome results
None listed