Advanced localised non-metastatic pancreatic cancer (LANPC)
Conditions
Interventions
Trade Name: Xeloda
Product Name: capecitabine
Pharmaceutical Form: Film-coated tablet
Product Name: gemcitabine
Pharmaceutical Form: Po
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting the following criteria may be included in the trial: 1. Age = 18 2. Histologically or cytologically proven malignancy of the pancreas 3. Locally advanced, non-metastatic, and inoperable (or operable but medically unfit for surgery) (as discussed at MDT) malignancy. The following types of interventions are allowed: a. palliative bypass procedure b. common bile duct stenting 4. Primary pancreatic lesion =7cm in diameter as measured by a CT scan of the thorax and abdomen that has been done within 4 weeks prior to the start of induction chemotherapy 5. WHO performance status 0-2 6. Neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and haemoglobin = 10g/dL 7. Adequate liver function tests: a. Serum bilirubin 50ml/min (Cockcroft & Gault) 9. Capable of giving, and given, informed consent 10. Potentially fertile participants should agree to use an adequate contraception method, which must be continued for 3 months after completion of chemotherapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If any of the following criteria apply, participants cannot be included in the trial: 1. Women who are pregnant or breast feeding 2. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease 3. Any participants with myocardial infarction or stroke within the last 6 months 4. Previous malignancies in the preceding 5 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 8. Lymphoma or neuroendocrine tumours of the pancreas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity, safety and feasibility of two chemoradiation treatments in the management of LANPC. If either is found to be active, safe and feasible to use it may be considered as experimental arm(s) of a future phase III trial. Primary objective: In each arm of the trial assess the 39 weeks (from registration) progression-free survival, defined according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria. ;Primary end point(s): 39 weeks (from registration) progression-free survival, defined according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria; Secondary Objective: In each arm of the trial assess: 1) Toxicity, during and after treatment using NCI CTCAE v.3.0. Also, SAEs will be collected in real time 2) Quality of life 3) Overall survival 4) Progression-free survival (time to event). 5) Radiotherapy quality assurance 6) Adherence to protocol 7) Change over time of CA19-9 response | — |
Countries
United Kingdom
Outcome results
None listed