Borderline resectable pancreatic cancer
Conditions
Interventions
Product Name: Gemcitabine
Product Code: SUB02324MIG
Pharmaceutical Form: Infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Borderline resectable mass in the pancreas head as defined by CT criteria 2. Histologically or cytologically proven pancreatic ductal adenocarcinoma 3. Able to undergo biliary drainage using a fully covered self expanding metal stent 4. Age over 18 years 5. WHO performace status 0,1 6. Platelets > 100x10^9/l; WBC > 3x 10^9/l; neutrophils > 1.5 x 10^9/l 7. Serum bilirubin greater or 1.5 ULN 8. Glomerular filtration rate estimated > 50ml/min according to Cockcroft & Gault (or equivalent value following local scale/formula) 9. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy. 10 written informed consent. 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. distant metastatic disease 2. previous or concurrent malignancy diagnosis, except curativelytreated (i) basal cell carcinoma of the skin ii) carcinoma in situ of cervix; breast, bladder; (iii) non muscle invasive transitional cell carcinoma of the bladder; (iv) previous cancers treated with curative intent, ending treatment more that 3 years ago. 3. serious medical od psychological condition precluding neoadjuvant treatment and surgical resection 4. previous chemotherapy ending < 3 years ago (exceptions may be given by case by the CI, such as methotrexate for rheumatoid arthritis) 5. Pregnancy 6. WHO performance status 2-4 7. NYHA Classification Grade III or IV 8. uncontrolled angina/ischaemic heart disease 9. patients with known malabsorptionn malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Recruitment rate: Recruitment will be measured by (i) recruitment rate by centre (ii) overall recruitment rate and (iii) graph comparing expected versus actual cumulative recruitment 2. Resection rate (R1 + R0): Resection rate will be measured using the total number of patients in the arm as baseline and, secondly, using the number of patients having explorative surgery. R1 and R0 resection margins will be included in the resection rate but not R2 resection. R1 will be defined as per the Royal College of Pathologists (RCP) report on Standards and datasets for reporting cancers. ;Secondary Objective: 1. R0 resection margin rate: recorded according to the RCP report on Standards and datasets for reporting cancers.2. Toxicity:graded according to the NCI-CTCAE v4. 3. Post-operative complication rate: recorded following surgery and classified acoording to existing guidelines. 4. Post-operative mortality rate: recorded as the 30 day mortality rate. 5. Response rate: according to RECIST 1.1 criteria. 6. Disease free survival rate: defined as number of days between date of surgery and disease recurrence 7. Local disease free survival rate: defined as number of days between date of surgery and local disease recurrence (CT scan). 8. Overall survival: defined as the number of days between date of randomisation and date of death due to any cause (event) or date of last follow-up if patient is still alive at time of analysis 9. Quality of life: QoL forms (EORTC QLQ-C30 version 3) will be completed as per the Table of Assessment in Section 8 of the trial Protocol. ;Primary end point(s): 1. Recriutment rate: (i) recruitment rate by centre (ii) overall recruitment rate (iii) graph comparing expected versus actual cumulative recruitment 2. Resection rate (R1+R0): Resection rate will be measured using the total number of patients in the arm as basseline and, secondly, using the number of patients having explorative surgery. R1 and R0 resection margins will be | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. R0 resection margin rate 2. Toxicity 3. Post operative complication rate 4. Post operative mortality rate 5. response rate 6. disease free survival rate 7.local disease free survival rate 8. overall survival 9. Quality of Life;Timepoint(s) of evaluation of this end point: Analysed at time of final analysis | — |
Countries
Finland, Germany, Ireland, United Kingdom
Contacts
Public ContactCharlotte Rawcliffe
University of Liverpool, Liverpool Cancer Trials Unit
Outcome results
None listed