MASTERPLAN
MASTERPLAN: A Randomised Phase II Study of MFOLFIRINOX and Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer with High Risk and Locally Advanced Disease
Trial summary:
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.
Receptor status / problem studied:
Inclusion criteria
1) Adults, aged between 18-75 years, with histological confirmation of pancreatic adenocarcinoma.
2) Any of the following:
|— a) T3 (tumour >4 cm).
|— b) Extrapancreatic extension.
|— c) Node positive (stage IIB).
|— d) Borderline resectable pancreatic cancer, locally advanced pancreatic cancer.
3) Measurable disease according to RECIST v1.1.
4) ECOG performance status 0-1.
5) Adequate renal and haematological function.
6) Adequate hepatic function. Defined as: Adequate hepatic function. Defined as bilirubin <1.5 X ULN (Upper Limit of Normal), AST + ALT <3.0 X ULN. In patients who have had a recent biliary drainage and whose bilirubin is descending, a value of ≤ 3 X N is acceptable.
7) Study treatment planned to start within 14 days of registration.
8) Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
9) Signed, written informed consent.
Exclusion criteria
1) Tumour size greater than 70mm.
2) Prior abdominal radiotherapy.
3) Evidence of metastatic disease on baseline radiologic investigations.
4) History of another malignancy within 2 years prior to randomisation, except adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, or any Stage 1 endometrial carcinoma. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary treatment.
5) Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
6) Neuroendocrine pancreatic carcinoma.
7) Life expectancy of less than 3 months.
8) Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomisation. Men must use a reliable means of contraception.
9) Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Trial Title
MASTERPLAN
Diagnosis
Pancreatic cancer
Type of trial
Collaborative
Type of treatement
Radiation Oncology
Phase
II