Phase
Condition
Pancreatic Cancer
Cancer
Pancreatic Disorders
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adults, aged between 18-75 years, with histological confirmation of pancreaticadenocarcinoma
- 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 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
Study Description
Connect with a study center
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
St George Hospital
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Royal North Shore Hospital
St Leonards, New South Wales 2065
AustraliaActive - Recruiting
Calvary Mater Newcastle
Waratah, New South Wales 2298
AustraliaActive - Recruiting
Westmead Hospital
Westmead, New South Wales 2145
AustraliaActive - Recruiting
ICON Cancer Centre, Gold Coast University Hospital
Southport, Queensland 4215
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
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