This is a prospective, multicentre randomised, phase II clinical trial, with randomisation 2:1 by minimisation and stratification by tumour stage, planned chemotherapy and institution.
MASTERPLAN: A randomised phase II study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease.
To be considered for the study you must meet the following criteria:
- Adults, aged between 18-75 years
- histologic confirmation of pancreatic adenocarcinoma
- Any of the following:
- T3 (tumour >4 cm)
- Node positive (Stage IIB)
- Borderlineresectablepancreatic cancer or
- Locally advanced pancreatic cancer
- ECOG 0-1
- Tumour size <70mm
- No evidence of metastasis
Arm A: Control (40 patients): Standard of care chemotherapy.
Arm B: Investigational (80 patients): Standard of care chemotherapy with the addition of SBRT.