AzTrials
AzTrials

Pancreatic CancerPhase 2MASTERPLANNCT04089150

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

A Phase 2 study testing Stereotactic Radiotherapy (SBRT), mFOLFIRINOX and Gemcitabine + Nab-paclitaxel in people with Pancreatic Cancer, run by Australasian Gastro-Intestinal Trials Group at 11 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Stereotactic Radiotherapy (SBRT), mFOLFIRINOX and Gemcitabine + Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
11 sitesAustralia
Study dates
1 Oct 2019to 30 Aug 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults, aged between 18-75 years, with histological confirmation of pancreatic adenocarcinoma
  • Any of the following
  • T3 (tumour >4 cm)
  • Extrapancreatic extension
  • Node positive (stage IIB)
  • Borderline resectable pancreatic cancer, locally advanced pancreatic cancer
Show all 13Show fewer
  • 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 whose bilirubin 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, timing and/or nature of required assessments
  • Signed, written informed consent

Who cannot join

  • 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 adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, or any Stage 1 endometrial carcinoma. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary treatment
  • Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
  • Neuroendocrine pancreatic carcinoma
Show all 9Show fewer
  • 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 potential must have a negative pregnancy test done within 7 days prior to registration. Men must use a reliable means of contraception
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol

Trial locations and contacts

11 sites in 1 country.

NHMRC CTC contact

+61 (0) 2 9562 5000

masterplan@ctc.usyd.edu.au

11 sites in 1 country

Australia11 sites, 11 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, 2217

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

    Recruiting

  • ICON Cancer Centre, Gold Coast University Hospital

    Southport, Queensland, 4215

    Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

About this study

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

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.

Read the 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.

Being tested
Stereotactic Radiotherapy (SBRT), mFOLFIRINOX, Gemcitabine + Nab-paclitaxel, Gemcitabine + Capecitabine, Pancreatoduodenectomy (Whipple procedure)
Keywords
stereotactic body radiotherapy, SBRT, chemotherapy, radiotherapy, surgery
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Radiotherapy (SBRT)Radiation

    Also called SBRT, Stereotactic Body Radiotherapy

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

  • mFOLFIRINOXDrug

    Also called modified regimen of oxaliplatin, leucovorin, irinotecan, and fluorouracil (5-FU)

    • 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

  • Gemcitabine + Nab-paclitaxelDrug

    Also called Gemcitabine + Abraxane

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

  • Gemcitabine + CapecitabineDrug

    Also called GemCap

    • 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

  • Pancreatoduodenectomy (Whipple procedure)Procedure or surgery

    Also called Whipple

    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.

Study groups in NCT04089150
Study groupRoleWhat they receive
Arm AActive comparator* 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
Receives: Drug: mFOLFIRINOX; Drug: Gemcitabine + Nab-paclitaxel; Drug: Gemcitabine + Capecitabine; Procedure: Pancreatoduodenectomy (Whipple procedure)
Arm BExperimental* 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
Receives: Radiation: Stereotactic Radiotherapy (SBRT); Drug: mFOLFIRINOX; Drug: Gemcitabine + Nab-paclitaxel; Drug: Gemcitabine + Capecitabine; Procedure: Pancreatoduodenectomy (Whipple procedure)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Locoregional control (Locoregional Response Rate LRR)

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

    Measured: Within 12 months of randomisation;

Secondary outcomes (10)

  1. Safety (NCI CTCAE v5.0)

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

    Measured: Safety Assessment before each cycle of chemotherapy, post chemotherapy treatment, following SBRT and surgery (if applicable) then at 3, 6, 9 and 12 months post-randomisation and 6 monthly during year 2, 3 and 4

  2. Surgical morbidity/mortality (Clavien grading system)

    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.

    Measured: At discharge post-surgery, 30 days and 90 days post surgery, up to 4 years

  3. Radiological response rates (RECIST v1.1)

    Compare radiologic response rates for chemotherapy +/- SBRT

    Measured: at baseline. In SBRT arm, post-initial chemotherapy (prior to SBRT). In both arms, 4-6 weeks post completion of initial treatment (prior to surgery), 3 ,6, 9 and 12 monthly during year 2, 3 and 4.

  4. Progression Free Survival (PFS) (RECIST v1.1)

    Compare 12-month progression free survival

    Measured: From randomisation to the time of first documented clinical or imaging relapse or date of death from any cause, whichever occurs first; up to 4 years

  5. Pathological response rates (College of American Pathology Tumour Regression Grade TRG)

    Compare pathologic response rates of chemotherapy +/- SBRT

    Measured: At SRBT/surgery compared to baseline;

  6. Surgical resection rates (Guidelines for the Evaluation of Resectability and Histology)

    Compare rates of surgical resection

    Measured: At surgery

  7. R0 resection rates (>1mm) (Synoptic PC histology reporting as outlined in Royal College of Pathologists of Australasia (RCPA)

    Compare R0 resection rates (>1 mm)

    Measured: At surgery

  8. Quality of Life (EORTC QLQ C30 and PAN26 QOL)

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

    Measured: Baseline, Day 1 of each cycle of chemotherapy, prior to SBRT, post initial chemotherapy +/- SBRT, prior to surgery, 30 days post end of treatment, at months 3, 6,9 and 12 post randomisation 6 monthly in years 2, 3 and 4.

  9. Deterioration-Free Survival (DFS) (EORTC QLQ C30)

    To assess overall net clinical benefit of treatment

    Measured: The time until the first of the following events: a 10-point deterioration in health status from baseline, disease progression, death, or treatment discontinuation;up to 4 years

  10. Overall Survival (OS)

    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.

    Measured: From the date of randomisation to date of death from any cause, or the date of last known alive; up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start1 Oct 2019
  3. Primary completionMay 2023 (estimated)
  4. Study completion30 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089150
Sponsor's protocol ID
CTC 0245/AGITG AG0118PS
Acronym
MASTERPLAN
Status last verified
Oct 2021
First submitted
4 Feb 2019
Last updated
22 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Oar A, Kneebone A, Sjoquist KM, Espinoza D, Lee M, Le H, Gholamrezaei L, Chu J, Lynam J, Mallesara G, Lee D, Vignarajah D, Ward I, Samra J, Barbour A, Whitehead A, Brooks S, Nicholson A, Wang TW, Ng W, Ali F, Siu D, Gaitan JL, Cook O, Moore A, Oostendorp MB, Yip S, Shakeshaft J, Pryor D, Nguyen N, Goldstein D; Australasian Gastro-Intestinal Trials Group (AGITG). Perioperative chemotherapy and stereotactic body radiotherapy versus perioperative chemotherapy alone in patients with high-risk, localised pancreatic cancer (MASTERPLAN): an open-label, phase 2, multicentre, randomised trial of the Australasian Gastro-Intestinal Trials Group. Lancet Oncol. 2026 Oct 23:S1470-2045(26)00532-2. doi: 10.1016/S1470-2045(26)00532-2. Online ahead of print.

    PubMed 42914998

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Radiotherapy (SBRT), mFOLFIRINOX and Gemcitabine + Nab-paclitaxel in people with Pancreatic Cancer, run by Australasian Gastro-Intestinal Trials Group at 11 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact NHMRC CTC (+61 (0) 2 9562 5000, masterplan@ctc.usyd.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Locoregional control (Locoregional Response Rate LRR) (time frame: Within 12 months of randomisation;). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in