ESPAC-5: European Study group for Pancreatic Cancer - Trial 5

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Pancreas; Cancer

• Registration Number: ISRCTN89500674
• Lead Sponsor: niversity of Liverpool (UK)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36521500/ (added 16/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-03
• Study Completion: 2021-01-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l
7. Serum bilirubin =1.5 ULN
8. Calculated creatinine clearance > 50ml/min
9. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy.
10. Written informed consent; Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Distant metastatic disease
2. History of previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix)
3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection
4. Previous chemotherapy or chemoradiotherapy
5. Pregnancy
6. WHO performance status 24
7. New York Heart Association Classification Grade III or IV
8. Patients with known malabsorption

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Recruitment rate<br> Recruitment rate will be measured by the proportion of centres that successfully engage in the study and by the overall recruitment. Centres will be classified as successfully engaged if the study has opened in a timely fashion and if they are achieving over 50% of the recruitment and randomisation rate estimated for their centre. The overall recruitment rate will be deemed successful if at least 80% of the centres have fully engaged in the study and the target rate has been achieved (100 patients in 24 months).<br><br> 2. Resection rate<br> An overall resection rate will be measured using the total number of patients at baseline. A second resection rate will also be measured using only the patients who undergo explorative surgery. R1 and R0 resection margins will be used when measuring the resection rate ? R2 resection margins will be excluded.<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration