NCT04089150

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Australasian Gastro-Intestinal Trials Group · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiotherapy (SBRT)	40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction
DRUG	mFOLFIRINOX	* 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
DRUG	Gemcitabine + Nab-paclitaxel	* Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2 * 28-day cycle, 3 cycles
DRUG	Gemcitabine + Capecitabine	* 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
PROCEDURE	Pancreatoduodenectomy (Whipple procedure)	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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-05-01
• Completion: 2023-08-30
• First posted: 2019-09-13
• Last updated: 2021-10-22

Locations

11 sites across 1 country: Australia