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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 Age Sponsor Protocol IDs
III Treatment Closed N/A Isrctn No: 11513444

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


Trial Lead Organisations

  • The Royal Liverpool and Broadgreen University Hospital Trust


Trial Start Date

Trial Not Open


References

1. Bramhall SR, Allum WH, Jones AG, Allwood A, Cummins C, Neoptolemos JP. Treatment and survival in 13,560 patients with pancreatic cancer, and incidence of the disease, in the West Midlands: an epidemiological study. Br J Surg 1995; 82(1):111-115.
2. Office for National Statistics. Cancer Survival Trends in England & Wales 1971-1995. 1999. Office for National Statistics.
3. HMSO. Great Britain Office of Population Censuses and Surveys: Cancer Statistics. 2000. HMSO. 1998


Trial Coordinator

Laura Marsh


Trial Coordinator Email Address

l.marsh@liv.ac.uk


Trial Coordinator Contact No

0151 794 8054


Website Treatment  

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 Endpoints  


Primary Outcome  

  • One year survival


Secondary Outcomes  

  • Quality of life
  • Median and two-year survival rates
  • Toxicity
  • Objective response rates
  • Assessment of pain

Eligibility  

Final data for the trial was collected in 2007. This data is now being analysed by the statisticians.

Links  

http://news.bbc.co.uk/1/hi/health/4397436.stm#GEMCAP on BBC News page