MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease
NCT ID: NCT04089150
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2019-10-01
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Gemcitabine + Nab-paclitaxel
* Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2
* 28-day cycle, 3 cycles
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
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.
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
Stereotactic Radiotherapy (SBRT)
40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction
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
Gemcitabine + Nab-paclitaxel
* Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2
* 28-day cycle, 3 cycles
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
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.
Interventions
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Stereotactic Radiotherapy (SBRT)
40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction
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
Gemcitabine + Nab-paclitaxel
* Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2
* 28-day cycle, 3 cycles
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Trans Tasman Radiation Oncology Group
OTHER
Australian Government Department of Health and Ageing
OTHER_GOV
Australasian Gastro-Intestinal Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Andrew Oar
Role: STUDY_CHAIR
ICON Gold Coast University Hospital, Southport, Queensland, AUS
Locations
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Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
ICON Cancer Centre, Gold Coast University Hospital
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Other Identifiers
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CTC 0245/AGITG AG0118PS
Identifier Type: -
Identifier Source: org_study_id