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

Phase 1

• Conditions: Borderline resectable pancreatic cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003932-56-DE
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-23
• Study Completion: 2021-02-03
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified