Brief Summary
The aim of this study is to assess the benefit of adding high precision radiotherapy to chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells and surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence for the treatment of pancreatic cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
Intervention/Treatment
- Surgery
- Drug: mFOLFIRINOX
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
- Drug: Capecitabine
Inclusion Criteria
- Adults, aged between 18-75 years, with pathologic confirmation of pancreatic adenocarcinomacancer arising from mucus-producing glands in organs.
- Patients who are treatment-naïve, or have been commenced on chemotherapy less than or equal to 28 days prior to randomisation.
- Any of the following: T3 (tumoura tissue mass that forms from groups of unhealthy cells greater than 4 cm), Extrapancreatic extension, Nodea small lump or mass of tissue in your body positive , Borderline resectable pancreatic cancer, locally advancedat a late stage, far along pancreatic cancer.
- Measurable disease according to RECIST v1.1.
- ECOG performance status 0-1.
- Adequate renal and haematological function.
- Adequate hepatic function. Defined as bilirubin less than 1.5 X ULN (Upper Limit of Normal), AST + ALT less than 3.0 X ULN. If a patient was recently stented with improving bilirubin, the patient can be randomised with bilirubin up to 3 x ULN provided chemotherapy is not administered until within the stated thresholds.
- Study treatment planned to start within 14 days of randomisation.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Signed, written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..