Borderline resectable pancreatic cancer. MedDRA version: 18.0 Level: LLT Classification code 10033608 Term: Pancreatic cancer resectable System Organ Class: 100000004864
Conditions
Interventions
Product Name: Gemcitabine
Product Code: SUB02324MIG
Pharmaceutical Form:
INN or Proposed INN: gemcitabine hydrochloride
CAS Number: 95058-81-4
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
University of Liverpool
Royal Liverpool and Broardgreen University Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Borderline resectable mass in the pancreatic head as defined by CT criteria. 2. Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants). 3. Able to undergo biliary drainage using a fully covered self expanding metal stent. 4. Age = 18 years. 5. WHO performance status 0, 1. 6. Platelets >100 x 10^9/l; WBC > 3 x 10^9/l; neutrophils > 1.5 x 10^9/l. 7. Serum bilirubin =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: 0 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 diagnoses, except: i) curatively-treated basal cell carcinoma of skin, ii) carcinoma in situ of cervix, iii) previous cancers treated with curative intent, ending treatment = 5 years ago. 3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection. 4. Previous chemotherapy ending < 5 years ago (exceptions may be given case by case by the CI, such as methotrexate for rheumatoid arthritis). 5. Pregnancy. 6. WHO performance status 2-4. 7. New York Heart Association Classification Grade III or IV. 8. Uncontrolled angina/ischaemic heart disease. 9. Patients with known malabsorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Recruitment Rate: Is it feasible to recruit and randomise patients with borderline resectable pancreatic cancer to receive immediate surgical exploration versus neoadjuvant chemotherapies or chemoradiotherapy? 2. Resection Rate: 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. R0 (resection margins free of tumour) and R1 (Tumour within 1 mm of resection margin) resection margins will be included in the resection rate but not R2 resection (tumour present at resection margin). ;Secondary Objective: 1. R0 resection margin rate. 2. Toxicity. Toxicity will be graded according to the NCI-CTCv4. 3. Post operative complication rate. Post operative morbidity will be recorded following surgery and classified according to existing guidelines. 4. Post operative mortality rate. Post operative mortality rate will be recorded as the 30 day mortality rate. 5. Response rate. Response rate will be recorded according to RECIST 1.1 criteria. 6. Disease free survival rate. DFS will be defined as number of days between date of surgery and disease recurrence (CT scan, +/- clinical assessment +/- CA19.9). 7. Local disease free survival rate. Local DFS will be defined as number of days between date of surgery and local disease recurrence (CT scan). 8. Overall survival. OS will be defined as the number of days between date of randomisation and date of death due to any cause or date of last follow-up if patient is still alive at time of analysis. 9. Quality of life. ;Primary end point(s): The primary outcome measures of the study are: 1. Recruitment rate 2. Resection rate (R0 and R1 resections);Timepoint(s) of evaluation of this end point: 1. 12 months and 24 months. 2. Analysed at time of final analysis. | — |
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
United Kingdom
Outcome results
None listed