ESPAC-5F: European Study Group for Pancreatic Cancer - Trial 5F

Conditions: Borderline resectable pancreatic cancer.
MedDRA version: 18.0Level: LLTClassification code 10033608Term: Pancreatic cancer resectableSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-003932-56-GB

Lead Sponsor: niversity of Liverpool

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

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

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.