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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04089150




Registration number
NCT04089150
Ethics application status
Date submitted
4/02/2019
Date registered
13/09/2019

Titles & IDs
Public title
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease
Scientific title
MASTERPLAN: A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease
Secondary ID [1] 0 0
CTC 0245/AGITG AG0118PS
Universal Trial Number (UTN)
Trial acronym
MASTERPLAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Stereotactic Radiotherapy (SBRT)
Treatment: Drugs - mFOLFIRINOX
Treatment: Drugs - Gemcitabine + Nab-paclitaxel
Treatment: Drugs - Gemcitabine + Capecitabine
Treatment: Surgery - Pancreatoduodenectomy (Whipple procedure)

Active comparator: Arm A - * 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

Experimental: Arm B - * 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


Treatment: Other: Stereotactic Radiotherapy (SBRT)
40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction

Treatment: Drugs: 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

Treatment: Drugs: Gemcitabine + Nab-paclitaxel
* Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2
* 28-day cycle, 3 cycles

Treatment: Drugs: 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

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Locoregional control (Locoregional Response Rate LRR)
Timepoint [1] 0 0
Within 12 months of randomisation;
Secondary outcome [1] 0 0
Safety (NCI CTCAE v5.0)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Surgical morbidity/mortality (Clavien grading system)
Timepoint [2] 0 0
At discharge post-surgery, 30 days and 90 days post surgery, up to 4 years
Secondary outcome [3] 0 0
Radiological response rates (RECIST v1.1)
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Progression Free Survival (PFS) (RECIST v1.1)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Pathological response rates (College of American Pathology Tumour Regression Grade TRG)
Timepoint [5] 0 0
At SRBT/surgery compared to baseline;
Secondary outcome [6] 0 0
Surgical resection rates (Guidelines for the Evaluation of Resectability and Histology)
Timepoint [6] 0 0
At surgery
Secondary outcome [7] 0 0
R0 resection rates (>1mm) (Synoptic PC histology reporting as outlined in Royal College of Pathologists of Australasia (RCPA)
Timepoint [7] 0 0
At surgery
Secondary outcome [8] 0 0
Quality of Life (EORTC QLQ C30 and PAN26 QOL)
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Deterioration-Free Survival (DFS) (EORTC QLQ C30)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
From the date of randomisation to date of death from any cause, or the date of last known alive; up to 4 years

Eligibility
Key inclusion criteria
* Adults, aged between 18-75 years, with histological confirmation of pancreatic adenocarcinoma
* 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 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
ICON Cancer Centre, Gold Coast University Hospital - Southport
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australasian Gastro-Intestinal Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans Tasman Radiation Oncology Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Australian Government Department of Health and Ageing
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Oar
Address 0 0
ICON Gold Coast University Hospital, Southport, Queensland, AUS
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
NHMRC CTC
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 2 9562 5000
Fax 0 0
Email 0 0
masterplan@ctc.usyd.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04089150