Status:
UNKNOWN
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease
Lead Sponsor:
Australasian Gastro-Intestinal Trials Group
Collaborating Sponsors:
Trans Tasman Radiation Oncology Group
Australian Government Department of Health and Ageing
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04089150
Start Date
October 1 2019
End Date
August 30 2023
Last Update
October 22 2021
Active Locations (11)
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1
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
2
St George Hospital
Kogarah, New South Wales, Australia, 2217
3
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
4
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065