ESPAC-3(v2)
Title
European Study Group for Pancreatic Cancer (ESPAC) Trial 3 (v2). Adjuvant Chemotherapies in Resectable Pancreatic Cancer
Basic Trial Information
| Phase | Type | Status | Sponsor | Protocol IDs |
| III | Treatment | Closed | University of Liverpool and RLBUHT | EUDRACT No: N/A ISRCTN No: 37494643 |
Trial Description
Purpose
Pancreatic cancer is one of the major causes of cancer death in Central and Northern European countries as well as in North America, Australasia and Japan 1. Initial treatment involves surgical resection Despite recent improvements in resection rates for localised pancreatic cancer, long-term survival following surgery alone remains poor with a median of 11-15 months, 2-year survival of 20-40% and 5-year survival of around 10% 2, 3. ESPAC-3 was formulated as a result of the ESPAC-1 study.
Latest Update
The trial is now closed to recruitment. Follow up data is now being collected ready for analysis.
Treatment/Intervention
ESPAC-3(v2) is a phase III, international, randomised controlled adjuvant trial in pancreatic cancer comparing 5FU and D-L-Folinic Acid vs. Gemcitabine. The trial is running internationally in over 160 sites in 16 different countries. The trial opened in 2002 and is aiming to finish later this year.
The trial design was amended in 2003 and the study is now called ESPAC-3(v2). Target recruitment for the amended trial is 1030 patients and to be suitable for the study,
Trial Endpoint
For patients with ductal adenocarcinoma of the pancreas randomised into the two-arm study:
- Is there any survival difference between gemcitabine and bolus 5FU + folinic acid when used as adjuvant therapy following resection?
For patients with ampullary or other pancreatic tumours randomised into the three-arm study:
- Does either adjuvant gemcitabine or 5FU + folinic acid improve survival compared to no additional treatment following resection of pancreatic cancer?
- Is there any survival difference between gemcitabine and 5FU + folinic acid when used as adjuvant therapy following resection?
Primary Outcome
- length of survival
Secondary outcomes
- Toxicity
- Quality of life
- 5-year survival
Trial Lead Organisations
Registry Information
Official Title
European Study Group for Pancreatic Cancer (ESPAC) Trial 3 (v2). Adjuvant Chemotherapies in Resectable Pancreatic Cancer
Links & other information
Trial Start Date
07/07/2000
