A study looking at the use of Mfolfirinox Chemotherapy And Stereotactic Radiotherapy for Patients with Locally Advanced pancreatic cancer to evaluate if this is a feasible treatment option with acceptable acute toxicity rates.

Phase 2

Active, not recruiting

• Conditions: Borderline Resectable Pancreatic Adenocarcinoma; Unresectable Pancreatic Adenocarcinoma; Cancer - Pancreatic

• Registration Number: ACTRN12617001642370
• Lead Sponsor: iverpool Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-19
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Age greater than or equal to 18 years and able to give informed consent.
Patients with histologically confirmed adenocarcinoma of the pancreas that is classified as BRPC or UPC, as per NCCN guidelines.
ECOG performance status 0 or 1.
Adequate bone marrow function (absolute neutrophil count ((ANC) greater than 1.5, platelets greater than 100).
Adequate liver function (albumin greater than 25 g/L, bilirubin less than or equal to 26 micromol/L; transaminases (ALT/AST) less than or equal to 5 times the upper limit of normal (ULN)).
Adequate renal function (creatinine less than or equal to 1.5 times the ULN).

Exclusion Criteria

Age 70 years and over.
Patients with resectable or metastatic pancreatic cancer.
Neuroendocrine pancreatic carcinoma.
Previous chemotherapy or abdominal radiotherapy.
Previous diagnosis of cancer within the last 5 years (excluding non-melanoma skin cancers, and carcinoma in situ).
Chronic diarrhoea or peripheral neuropathy equal to or greater than grade 2.
Pregnancy.
Non-controlled coronary artery disease or myocardial infarction within the last 6 months.
Known hypersensitivity to 5-fluorouracil, irinotecan, oxaliplatin, capecitabine.
Patient will be ineligible for fMRI if they have contraindication to MRI. They will still have other imaging performed (18FDG-PET and 18F-MISO).
Patients with portal hypertension, coagulopathy or an inaccessible portal vein will not have portal vein blood sampling done as part of CTC/cPSC sub-study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess if mFOLFIRINOX chemotherapy and SBRT is a feasible neoadjuvant treatment option with acceptable acute toxicity rates for patients with BRPC or UPC.<br>This will be assessed by the EORTC QLQ-C30 and PAN26 QoL and toxicity data as per CTCAE V4 criteria. [6 weeks following completion of SBRT and then 3 monthly following SBRT for 1 year then 6 monthly for another year, ]