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* Option 1: fluorouracil(5-FU)/leucovorin/irinotecan/oxaliplatin (mFOLFIRINOX) (6 cycles)
* Option 2: gemcitabine + nab-paclitaxel (3 cycles)
* Resectable patients receive surgery 6 weeks post completion of initial chemotherapy
* Unresectable patients continue with ongoing chemotherapy (option 1 or option 2)
* Unresectable patients with locoregional progression or metastatic disease, chemotherapy treatment at the discretion of treating medical oncologist
* Adjuvant chemotherapy for resectable patients to begin within 8 weeks after surgery
* For patients who received option 1 chemotherapy: 12 weeks of mFOLFIRINOX
* For patients who received option 2 chemotherapy: 12 weeks of mFOLFIRINOX or 12 additional weeks of gemcitabine/capecitabine

* Option 1: fluorouracil(5-FU)/leucovorin/irinotecan/oxaliplatin (mFOLFIRINOX) (6 cycles)
* Option 2: gemcitabine + nab-paclitaxel (3 cycles)
* Stereotactic Radiotherapy (SBRT) to commence within 3 weeks of completing initial chemotherapy: 40 Gray (Gy) in 5 fractions over 2 weeks
* Resectable patients receive surgery 6 weeks post completion of initial chemotherapy
* Unresectable patients continue with ongoing chemotherapy (option 1 or option 2)
* Unresectable patients with locoregional progression or metastatic disease, chemotherapy treatment at the discretion of treating medical oncologist
* Adjuvant chemotherapy for resectable patients to begin within 8 weeks after surgery
* For patients who received option 1 chemotherapy: 12 weeks of mFOLFIRINOX
* For patients who received option 2 chemotherapy: 12 weeks of mFOLFIRINOX or 12 additional weeks of gemcitabine/capecitabine

40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction

Stereotactic Radiotherapy (SBRT)

* Day 1: oxaliplatin 85mg/m2 + irinotecan 150mg/m2 + leucovorin 50mg
* 5-FU 2400mg/m2 continuous IV infusion, 46 hour continuous infusion
* 14-day cycle, 6 cycles

mFOLFIRINOX

* Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2
* 28-day cycle, 3 cycles

Gemcitabine + Nab-paclitaxel

* Week 1, 2 and 3, qw: 1000 mg/m2 gemcitabine
* 21 days continuous: 830 mg/m2 oral capecitabine + 7 days rest
* 28-day cycle, 3 cycles

Gemcitabine + Capecitabine

R0 resection. When the tumour is within the head of the pancreas, a standard Whipple's procedure and level 2/3 dissection with modification to obtain margin clearance will be offered. For lesions in the tail, a standard modular resection will be offered.

Pancreatoduodenectomy (Whipple procedure)

NHMRC CTC

Andrew Oar

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.

This is a prospective, multicentre randomised, phase II clinical trial to evaluate safety and activity of stereotactic body radiotherapy (SBRT) in addition to chemotherapy in patients with high-risk and borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). High risk defined as any patient with tumour \>4cm, extrapancreatic extension or node positive disease.

MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

MASTERPLAN: A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

The study will be conducted in accordance with applicable Privacy Acts and Regulations. All data generated in this study will remain confidential. All information will be stored securely at the NHMRC CTC, University of Sydney and will only be available to people directly involved with the study.

Personal data identifying trial participants will be held securely at the NHMRC CTC for the purpose of follow up if the patient is unable to/wishes to discontinue clinic based follow-up.

The list of blood biomarkers and their measurement will be updated when confirmed.

The list of tissue biomarkers and their measurement will be updated when confirmed.

Proportion of patients who are willing to use electronic device vs. paper format, Analysis of demographic data and assessing data quality between the group

To determine if the addition of SBRT to chemotherapy improves locoregional control;

Compare acute and late side effects from chemotherapy +/- SBRT

Length of stay, death within 30 days, frequency and severity of adverse events. Hospital admission during surgery will be calculated from day of surgery to date of discharge from acute care hospitalisation. The length of stay in acute hospital care will include intensive care admissions.

Compare radiologic response rates for chemotherapy +/- SBRT

Compare 12-month progression free survival

Compare pathologic response rates of chemotherapy +/- SBRT

To assess the impact of the regimens on quality of life of patients

To assess overall net clinical benefit of treatment

OS is defined as the interval from the date of randomisation to date of death from any cause, or the date of last known alive. Participants will be censored at the date of commencement of the subsequent anti-cancer therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease	NCT04089150	Pancreatic Canc...	Stereotactic Ra... mFOLFIRINOX Gemcitabine + N... Gemcitabine + C... Pancreatoduoden...	18 Years - 75 Years	Australasian Gastro-Intestinal Trials Group
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease	NCT04089150	Pancreatic Canc...	Stereotactic Ra... mFOLFIRINOX Gemcitabine + N... Gemcitabine + C... Pancreatoduoden...	18 Years - 75 Years	Australasian Gastro-Intestinal Trials Group
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease	NCT04089150	Pancreatic Canc...	Stereotactic Ra... mFOLFIRINOX Gemcitabine + N... Gemcitabine + C... Pancreatoduoden...	18 Years - 75 Years	Australasian Gastro-Intestinal Trials Group

Spots Global Cancer Trial Database for pancreatoduodenectomy (whipple procedure)