- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089150
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease (MASTERPLAN)
MASTERPLAN: A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: NHMRC CTC
- Phone Number: +61 (0) 2 9562 5000
- Email: masterplan@ctc.usyd.edu.au
Study Locations
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Recruiting
- Chris O'Brien Lifehouse
-
Kogarah, New South Wales, Australia, 2217
- Recruiting
- St George Hospital
-
Randwick, New South Wales, Australia, 2031
- Recruiting
- Prince Of Wales Hospital
-
St Leonards, New South Wales, Australia, 2065
- Recruiting
- Royal North Shore Hospital
-
Waratah, New South Wales, Australia, 2298
- Recruiting
- Calvary Mater Newcastle
-
Westmead, New South Wales, Australia, 2145
- Recruiting
- Westmead Hospital
-
-
Queensland
-
Southport, Queensland, Australia, 4215
- Recruiting
- ICON Cancer Centre, Gold Coast University Hospital
-
Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Recruiting
- Royal Adelaide Hospital
-
-
Victoria
-
Melbourne, Victoria, Australia, 3000
- Recruiting
- Peter MacCallum Cancer Centre
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- The Alfred Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
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 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A
|
Other Names:
Other Names:
Other Names:
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.
Other Names:
|
Experimental: Arm B
|
Other Names:
Other Names:
Other Names:
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.
Other Names:
40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Locoregional control (Locoregional Response Rate LRR)
Time Frame: Within 12 months of randomisation;
|
To determine if the addition of SBRT to chemotherapy improves locoregional control;
|
Within 12 months of randomisation;
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (NCI CTCAE v5.0)
Time Frame: 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
|
Compare acute and late side effects from chemotherapy +/- SBRT
|
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
|
Surgical morbidity/mortality (Clavien grading system)
Time Frame: At discharge post-surgery, 30 days and 90 days post surgery, up to 4 years
|
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.
|
At discharge post-surgery, 30 days and 90 days post surgery, up to 4 years
|
Radiological response rates (RECIST v1.1)
Time Frame: 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.
|
Compare radiologic response rates for chemotherapy +/- SBRT
|
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.
|
Progression Free Survival (PFS) (RECIST v1.1)
Time Frame: 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
|
Compare 12-month progression free survival
|
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
|
Pathological response rates (College of American Pathology Tumour Regression Grade TRG)
Time Frame: At SRBT/surgery compared to baseline;
|
Compare pathologic response rates of chemotherapy +/- SBRT
|
At SRBT/surgery compared to baseline;
|
Surgical resection rates (Guidelines for the Evaluation of Resectability and Histology)
Time Frame: At surgery
|
Compare rates of surgical resection
|
At surgery
|
R0 resection rates (>1mm) (Synoptic PC histology reporting as outlined in Royal College of Pathologists of Australasia (RCPA)
Time Frame: At surgery
|
Compare R0 resection rates (>1 mm)
|
At surgery
|
Quality of Life (EORTC QLQ C30 and PAN26 QOL)
Time Frame: 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.
|
To assess the impact of the regimens on quality of life of patients
|
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.
|
Deterioration-Free Survival (DFS) (EORTC QLQ C30)
Time Frame: 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
|
To assess overall net clinical benefit of treatment
|
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
|
Overall Survival (OS)
Time Frame: From the date of randomisation to date of death from any cause, or the date of last known alive; up to 4 years
|
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.
|
From the date of randomisation to date of death from any cause, or the date of last known alive; up to 4 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory biomarker analysis of blood
Time Frame: baseline, prior to SBRT (Arm B only), insertion of fiducial markers (Arm B, optional), post initial treatment, at surgery (optional, at selected sites), 6 and12 months post randomisation and at progression, up to 5 years
|
The list of blood biomarkers and their measurement will be updated when confirmed.
|
baseline, prior to SBRT (Arm B only), insertion of fiducial markers (Arm B, optional), post initial treatment, at surgery (optional, at selected sites), 6 and12 months post randomisation and at progression, up to 5 years
|
Exploratory biomarker analysis of tissue
Time Frame: Diagnosis (archival tissue), at time of fiducial insertion (Arm B, optional), surgical resection (for resectable patients) and at time of progression (optional), up to 5 years.
|
The list of tissue biomarkers and their measurement will be updated when confirmed.
|
Diagnosis (archival tissue), at time of fiducial insertion (Arm B, optional), surgical resection (for resectable patients) and at time of progression (optional), up to 5 years.
|
ePRO Acceptability
Time Frame: Baseline, Day 1 of each cycle of chemotherapy, 2 weeks post initial chemotherapy(SBRT arm), 4-6 weeks post initial chemotherapy +/- SBRT, 30 days post end of treatment, at months 3, 6,9 and 12 post randomisation 6 monthly in years 2, 3 and 4.
|
Proportion of patients who are willing to use electronic device vs. paper format, Analysis of demographic data and assessing data quality between the group
|
Baseline, Day 1 of each cycle of chemotherapy, 2 weeks post initial chemotherapy(SBRT arm), 4-6 weeks post initial chemotherapy +/- SBRT, 30 days post end of treatment, at months 3, 6,9 and 12 post randomisation 6 monthly in years 2, 3 and 4.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Andrew Oar, ICON Gold Coast University Hospital, Southport, Queensland, AUS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Gemcitabine
- Paclitaxel
- Fluorouracil
- Capecitabine
- Oxaliplatin
- Leucovorin
- Irinotecan
Other Study ID Numbers
- CTC 0245/AGITG AG0118PS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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