Localised advanced non-metastatic pancreatic cancer (LANPC) Cancer Pancreatic cancer
Conditions
Interventions
Patients will be recruited over a period of approximately 24 months. Patients satisfying inclusion and exclusion criteria will receive three cycles (12 weeks) of GEMCAP chemotherapy (each four-week cy
patients will be followed up until week 52.
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent 2. Aged greater than or equal to 18 years, either sex 3. Histologically or cytologically confirmed inoperable (or medically unfit for surgery) adenocarcinoma of the pancreas 4. Chosen for non-surgical therapy by a specialised Multi-Disciplinary Team 5. World Health Organization (WHO) performance status 0 - 2 6. Neutrophils greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 100 x 10^9/L and haemoglobin greater than or equal to 10 g/dL 7. Adequate liver function tests: 7.1. Serum bilirubin less than 35 µmol/l. In patients who have had a recent biliary drain and whose bilirubin is descending, a value of less than or equal to 50 µmol/L is acceptable. 7.2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN) 7.3. Alkaline phosphatase less than or equal to 5 x ULN 8. Adequate renal function (glomerular filtration rate [GFR] greater than 50 ml/min Cockcroft and Gault) 9. Women and men of child-bearing potential should agree to use an adequate contraception method, which must be continued for three months after completion of chemotherapy
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breast feeding 2. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease 3. Any patient with myocardial infarction or stroke within the last six months 4. No previous malignancies in the preceding five years except for in situ cancer of the uterine cervix and adequately treated basal cell skin carcinoma and early stage malignancy 5. Renal abnormalities such as polycystic kidneys or hydronephrosis or ipsilateral single kidney 6. Previous radiotherapy to upper abdomen 7. Recurrent cancer following definitive pancreatic surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In each arm of the trial: nine-month (from registration) progression-free survival, defined according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| In each arm of the trial: 1. Toxicity, during and after treatment using National Cancer Institute Common Terminology Criteria for Adverse Events version three (NCI CTCAE v 3.0). Toxicity will be measured at baseline, weeks 5, 9, 13 (i.e. at the end of each GEMCAP cycle - prior to CRT), 17, 18, 19, 20, 21, 22 (during CRT), 23, 26, 39 and 52 (follow-up). Also, serious adverse events (SAEs) will be collected in real time. 2. Quality of life, measured at baseline, week 17, 23, 26, 39 and 52 3. Overall 12-month survival and time from registration to death by any cause. Those still alive will be censored at date last seen. 4. Objective disease response (based on RECIST criteria) 5. Progression-free survival (time to event). Time from registration to any progression (based on RECIST criteria) and/or death. Those progression-free and alive will be censored at date last seen. 6. Radiotherapy quality assurance (RT QA); planning will be between weeks 13 - 16, planned assessment will be during week 17 7. Tumour marker CA19-9, measured at baseline, weeks 17, 39 and 52 | — |
Countries
United Kingdom
Outcome results
None listed