Phase III adjuvant trial in pancreatic cancer comparing 5-Fluorouracil (5FU) and D-L-folinic acid versus gemcitabine versus no adjuvant treatment

Phase 3

Completed

• Conditions: Pancreatic cancer; Cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN37494643
• Lead Sponsor: Cancer Research UK (CRUK) (UK)

Brief Summary

2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20823433 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22782416 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24301456 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24419109 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-01
• Study Completion: 2008-05-07
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.1. Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas
1.2. Patients with other cancer may be included who have had complete macroscopic resection for unusual malignancies of the pancreas; cancer of the periampullary region; cancer of the intra-pancreatic bile duct; periampullary cancer of uncertain origin
2. Histological confirmation of the primary diagnosis
3. Histological examination of all resection margins
4. No evidence of malignant ascites, liver metastases, spread to other distant abdominal organs, peritoneal metastases, spread to extra-abdominal regions
5. A World Health Organisation (WHO) performance status =2
6. Fully recovered from surgery and fit to take part in the trial. Life expectancy of more than 3 months
7. Able to attend for administration of adjuvant therapy
8. Able to attend for long-term follow-up
9. No previous or concurrent malignancy diagnoses
10. No serious medical or psychological condition precluding adjuvant treatment
11. Fully informed written consent given

Exclusion Criteria

Does not match inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Added 03/09/09:<br> 1. Survival at 2 and 5 years<br> 2. Toxicity<br> 3. Quality of life<br> 4. Relapse free survival<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration