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

NCT04089150 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-10-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Trans Tasman Radiation Oncology Group

    collaborator OTHER

  • Australian Government Department of Health and Ageing

    collaborator OTHER_GOV

  • Australasian Gastro-Intestinal Trials Group

    lead NETWORK

Principal Investigators

  • Andrew Oar · ICON Gold Coast University Hospital, Southport, Queensland, AUS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-05-31
Completion
2023-08-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089150 on ClinicalTrials.gov