GEMCAP
Title
A phase III multicentre randomised clinical trial comparing gemcitabine alone or in combination with capecitabine for the treatment of patients with advanced pancreatic cancer.
Basic Trial Information
| Phase | Type | Status | Sponsor | Protocol IDs |
| III | Treatment | Closed | EUDRACT No: ISRCTN No: 11513444 |
Trial Description
Purpose
Pancreatic cancer represents one of the most important oncological challenges. This is reflected in the poor overall one-year survival of around 10% and long-term survival of only 0.4% 1. It is one of the top ten causes of cancer death in the Western world and is responsible for 6,000 deaths per year in the UK and around 40,000 per year in Europe 2,3
Latest Update
Final data for the trial was collected in 2007. This data is now being analysed by the statisticians.
Treatment/Intervention
A phase III, multicentre, randomised clinical trial comparing gemcitabine alone or in combination with capecitabine for the treatment of patients with advanced pancreatic cancer. GEMCAP recruited a total of 533 patients from 70 sites within the UK. The trial opened in May 2002 and closed to recruitment in 2005. The data is now with the statisticians who are producing the final analysis. Results should be out later this year.
Trial Endpoint
Primary Outcome
- One year survival
Secondary outcomes
- Quality of life
- Median and two-year survival rates
- Toxicity
- Objective response rates
- Assessment of pain
Trial Lead Organisations
- The Royal Liverpool and Broadgreen University Hospital Trust
Registry Information
Official Title
A phase III multicentre randomised clinical trial comparing gemcitabine alone or in combination with capecitabine for the treatment of patients with advanced pancreatic cancer.
