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

Phase 1

Active, not recruiting

• Conditions: Borderline resectable pancreatic cancer.; MedDRA version: 19.0Level: LLTClassification code 10033608Term: Pancreatic cancer resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-30
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Borderline resectable mass in the pancreatic head as defined by CT criteria (see protocol Table 1).

2. Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants).

3. Able to undergo biliary drainage using a covered, partially covered or uncovered self-expanding metal stent.

4. Age = 18 years.

5. WHO performance status 0, 1.

6. Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/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:
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 curatively-treated (i) basal cell
carcinoma of 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 = 3 years ago.

3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection.

4. Previous chemotherapy ending < 3 years ago (exceptions may be given case by case by the CI, such as methotrexate for rheumatoid arthritis).

5. Pregnancy.

6. WHO status 2-4.

7. New York Heart Association Classification Grade III or IV.

8. Uncontrolled Angina/ischaemic heart disease

9. Patients with known malabsorption.

Study & Design

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