Pancreatic cancer Cancer Malignant neoplasm of pancreas
Conditions
Interventions
1. 5-FU and Folinic Acid: Folinic Acid D-L form: 20 mg/m2 iv bolus injection followed by 5-FU: 425 mg/m2 iv bolus injection given on 5 consecutive days every 28 days for six cycles (24 weeks)
Sponsors
Cancer Research UK (CRUK) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Does not match inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 03/09/09: 1. Survival at 2 and 5 years 2. Toxicity 3. Quality of life 4. Relapse free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
England, United Kingdom
Outcome results
None listed