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

Last updated: October 15, 2021
Sponsor: Australasian Gastro-Intestinal Trials Group
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Cancer

Pancreatic Disorders

Treatment

N/A

Clinical Study ID

NCT04089150
CTC 0245/AGITG AG0118PS
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, aged between 18-75 years, with histological confirmation of pancreaticadenocarcinoma
  • Any of the following
  1. T3 (tumour >4 cm)
  2. Extrapancreatic extension
  3. Node positive (stage IIB)
  4. Borderline resectable pancreatic cancer, locally advanced pancreatic cancer
  • Measurable disease according to RECIST v1.1
  • ECOG performance status 0-1
  • Adequate renal and haematological function
  • 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 whosebilirubin is descending, a value of ≤ 3 X N is acceptable
  • Study treatment planned to start within 14 days of registration
  • Willing and able to comply with all study requirements, including treatment, timingand/or nature of required assessments
  • Signed, written informed consent

Exclusion

Exclusion Criteria:

  • Tumour size greater than 70mm
  • Prior abdominal radiotherapy
  • Evidence of metastatic disease on baseline radiologic investigations
  • History of another malignancy within 2 years prior to randomisation, except adequatelytreated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinomaof the skin, superficial transitional cell carcinoma of the bladder, or any Stage 1endometrial carcinoma. Patients with a history of other malignancies are eligible ifthey have been continuously disease free for at least 2 years after definitive primarytreatment
  • Concurrent illness, including severe infection that may jeopardise the ability of thepatient to undergo the procedures outlined in this protocol with reasonable safety
  • Neuroendocrine pancreatic carcinoma
  • Life expectancy of less than 3 months
  • Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal,infertile, or use a reliable means of contraception. Women of childbearing potentialmust have a negative pregnancy test done within 7 days prior to registration. Men mustuse a reliable means of contraception
  • Serious medical or psychiatric conditions that might limit the ability of the patientto comply with the protocol

Study Design

Total Participants: 120
Study Start date:
October 01, 2019
Estimated Completion Date:
August 30, 2023

Study 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.

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • ICON Cancer Centre, Gold Coast University Hospital

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

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