PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable … (NCT04176952) | Clinical Trial Compass
TerminatedPhase 2
PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer
Stopped: Due to funding being withdrawn
United Kingdom31 participantsStarted 2019-03-05
Plain-language summary
PRIMUS 002 is looking at 2 different chemotherapy regimens in the neo-adjuvant setting for pancreatic cancer. Each treatment will be given for 3 months prior to surgery
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient has been enrolled in the Precision-Panc Master Protocol and their tissue has been deemed suitable for Next Generation Sequencing analysis (a Precision-Panc Master Protocol identifier will be required at the time of study enrolment)
✓. Signed informed consent given for PRIMUS 002 study
✓. Age ≥ 16 years
✓. Resectable or borderline resectable pancreatic cancer as defined by National Comprehensive Cancer Network criteria following discussion at the Multi Disciplinary Team
✓. Measurable Disease as per RECIST 1.1
✓. Histological or cytologically proven pancreatic ductal adenocarcinoma (including variants)
✓. Able to undergo biliary drainage using a covered or partially covered self-expanding metal stent if jaundiced
✓. Eastern Cooperative Oncology Group performance status 0 and 1
Exclusion criteria
✕. Distant metastatic disease
✕. History of previous or concurrent malignancy diagnosis (except curatively treated basal cell carcinoma of skin or carcinoma in situ of cervix) in the last 3 years
✕. Prior chemotherapy or CRT for pancreatic cancer
✕. Known hypersensitivity for any component of any study drug
What they're measuring
1
Time to progression post FOLFOX-A induction treatment
Timeframe: CT scans will take place at baseline, pre chemoradiotherapy and pre surgery, over approximately 6 months
. Active infection including Herpes Zoster and chickenpox
✕. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.
✕. Serious medical or psychological condition precluding neo-adjuvant treatment and surgical resection
✕. New York Heart Association Classification Grade III or IV