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This new UK national Phase III trial designed by the pancreas subgroup of the NCRI Upper GI Clinical Studies Group and funded by Cancer Research UK opened on 5th March 2007.
Dr Gary Middelton of Royal Surrey Hospital is the chief investigator for the trial and it is being run from the Liverpool Cancer Trials Unit.
The trial compares combination gemcitabine and capecitabine chemotherapy with concurrent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancreatic cancer. Telomerase vaccine therapy has shown benefit in pancreatic cancer and is being trialled in combination with GemCap chemotherapy. The telomerase vaccine, GV1001, has been developed by Danish-based biotech company Pharmexa.
When this page was last updated on 27th December 2007 the trial was already open to patients at 32 hospitals around the UK:
Aberdeen Royal Infirmary
Addenbrookes Hospital, Cambridge
Bristol Haematology and Oncology Centre
Christie Hospital, Manchester
Clatterbridge Centre for Oncology, Merseyside
Glan Clwyd Hospital, North Wales
Guys & St Thomas Hospital, London
Huddersfield Royal Infirmary, Yorkshire
Newcastle General Hospital
Norfolk and Norwich University Hospital
North Hampshire NHS Trust, Basingstoke
Peterborough District Hospital
Poole Hospital NHS Trust
Portsmouth Oncology Centre
Royal Bournemouth Hospital
Royal Cornwall Hospital, Truro
Royal Free Hospital, London
Royal Liverpool University Hospital
Royal Marsden Hospital (Surrey)
Royal Marsden Hospital (London)
Southampton University Hospital
Royal Surrey County Hospital, Guildford
Salisbury District Hospital
St. Bartholomew's Hospital, London
Sussex Oncology Centre,Royal Sussex County Hospital, Brighton.
Torbay District General Hospital
Weston Park Hospital, Sheffield
Yeovil District Hospital, Somerset
Worthing Hospital, West Sussex
Mount Vernon Cancer Centre, Northwood, Middlesex
Darent Valley Hospital, Dartford, Kent
Ipswich Hospital
and more sites are due to open soon. 32 other centres have expressed interest in joining. More information from Liverpool Cancer Trials Unit and CancerHelp UK. See the most recent list of open sites on the Liverpool Cancer Trials Unit web-site and potential future sites.
Patients with non-resectable pancreatic cancer will be randomly distributed into one of three arms of the trial:
• 370 patients will be treated with gemcitabine and capecitabine in a standard treatment
• 370 patients will be treated first with gemcitabine and capecitabine for eight weeks, following which they will be treated with GV1001
• 370 patients will be treated with gemcitabine and capecitabine and with GV1001 at the same time
The research team aims to find whether the patients treated with a combination of GV1001 and chemotherapy live longer than patients who only receive chemotherapy. It is not expected that GV1001 will cure patients, but that treatment will prolong their lives and that a small proportion of the patients may experience significantly longer survival. The first patient was randomised on 29th March 2007.
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