PRIMUS002: A study looking at two neo-adjuvant chemotherapy treatments for pancreatic cancer in patients whose cancer is able to be operated o
- Conditions
- Pancreatic cancerCancer
- Registration Number
- ISRCTN34129115
- Lead Sponsor
- HS Greater Glasgow and Clyde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 31
1. Patient has provided written informed consent and is registered to the PRECISION PANC master protocol
2. Signed informed consent given for PRIMUS 002 study
3. Age =16 years
4. Resectable or borderline resectable pancreatic cancer as defined by RECIST v1.1 criteria following discussion at the MDT
5. Measurable Disease as per RECIST 1.1
6. Histological or cytologically proven pancreatic ductal adenocarcinome (including variants)
7. Able to undergo biliary drainage using a covered or partially covered self-expanding metal stent if jaundiced
8. ECOG performance status 0 and 1
9. Adequate liver/bone marrow function as defined by:
9.1. Neutrophils = 1.5 x 109/l
9.2. Platelets = 100 x 109/l
9.3. Haemoglobin = 9.0g/dL
9.4. WBC = 3 x 109/l
9.5. Total bilirubin = 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndrome
9.6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (and <5 x ULN in the presence of liver metastases)
9.7. Estimated creatinine clearance > 60 mL/min
10. Negative serum Human Chorionic Gonadotropin (HCG) test for females with child bearing potential. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential
11. Woman of child bearing potential, and men with female partners of child bearing potential, must agree to use adequate contraceptive measures (see section 8.1.8.1) for the duration of the study and for up to 6 months after the completion of study treatment.
12. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy
1. Unable to obtain sufficient tissue for NGS analysis
2. Distant metastatic disease
3. History of previous or concurrent malignancy diagnosis (except curatively treated basil cell carcinoma of skin or carcinoma in situ of cervix)
4. Prior chemotherapy or chemoradiotherapy (exceptions may be given case by case by the Chief Investigator (CI), such as methotrexate for rheumatoid arthritis)
5. Known hypersensitivity for any component of any study drug
6. Active infection including Herpes Zoster and chickenpox
7. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.
8. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection
9. New York Heart Association Classification Grade III or IV
10. Uncontrolled angina/ischaemic heart disease
11. Major surgery within 28 days prior to trial entry
12. Any patients receiving treatment with brivudin, sorivudin and analogues
13. Any patient with severe diarrhoea.
14. Patients with known malabsorption
15. Patients with known or suspected DPD (dihydropyrimidine dehydrogenase) deficiency.
16. Grade = 2 peripheral neuropathy
17. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Time to progression following FOLFOX-A treatment is assessed through CT scans at baseline, prior to radiotherapy and prior to surgery. Further scans will be performed as per standard of care to progression.<br>2. Efficacy of proposed biomarkers in predicting disease progression rates in FOLFOX-A arm. Tissue samples will be collected from the patients at baseline (under the Precision Panc Master Protocol), prior to radiotherapy and at surgery/progression.
- Secondary Outcome Measures
Name Time Method