ESPAC-1
Title
European Study Group for Pancreatic Cancer Trial 1 - Adjuvant Therapy in Operable Pancreatic Cancer
Basic Trial Information
| Phase | Type | Status | Sponsor | Protocol IDs |
| III | Treatment | Closed | EUDRACT No: N/A ISRCTN No: N/A |
Trial Description
Purpose
The aim was to try and establish whether giving chemoradiotherapy for six weeks immediately after surgery, or chemotherapy for six months or a combination of both could improve the long-term survival from surgery. At its inception many rejected the idea because not only was it perceived that the post- operative mortality was too high but that the post-operative complication was excessive and the patients so debilitated that the trial would fail. Moreover the trial was seeking to recruit at least 280 patients - considered to be almost an impossible task given that the previous largest adjuvant trial (from the USA) comprised only 43 patients. Three of the largest pancreatic cancer surgical groups in Europe (HG Beger, M Büchler; C Bassi, P Pederzoli; JP Neoptolemos) came together to form ESPAC.
Latest Update
Recruitment into ESPAC-1 indicating the activity since 1994 of the three main randomization centres in the UK, Switzerland and Germany and from 1997, France.
With continued Cancer Research UK support the ESPAC team has now embarked on the ESPAC-3 (v2) Trial , which aims to confirm the benefit of adjuvant chemotherapy and identify the optimum agent. This trial aims to recruit 660 patients and has opened to recruitment. Centres throughout Europe, Australia, Canada, Japan and New Zealand are planning to work with ESPAC in order to complete this trial in a timely manner.
The first phase of the human genome project has just been completed and staggeringly we find that we are all made up of only 30,000-40,000 genes, many of which are already known. This is a number that lies within the grasp of human understanding. The complete molecular understanding of pancreas cancer will lead to its cure. Already there are exciting clinical trials based on this knowledge. These gene therapy trials, which are in progress or soon to start, include immunization against mutant KRAS oncogene, replacement of the p16 and p53 tumour suppresser genes and gene directed proenzyme drug therapy to dramatically boost the level of cytotoxic agents within pancreatic cancer cells.
There is still a long way to go however, before we can really cut a swathe through today's grim mortality statistics of pancreatic cancer.
Treatment/Intervention
Between February 1994 and February 2000 83 clinicians in 61 cancer centres across 11 European countries recruited 591 patients with resected pancreatic cancer into the study. The preliminary results showed that survival after surgery was much better than expected. Moreover adding chemotherapy probably increased survival even further - and equally important - the use of chemoradiotherapy (commonly used in the USA) was of NO BENEFIT. Quality of life analysis also revealed that this was not globally affected by any of the adjuvant treatments. Thus we had shown, that even older patients could withstand not only the major surgery needed to resect pancreatic cancer but also that they could potentially benefit from additional cytotoxic treatment. The Government recommendations to concentrate the care of pancreatic cancer patients into specialized regional centres came as an added bonus.
Trial Endpoint
Assess the role of adjuvant post-operative radiotherapy with intravenous 5-FU during treatment.
Primary Outcome
Secondary outcomes
Trial Lead Organisations
The ESPAC-1 adjuvant trial received the support of Cancer Research UK, which was organized from the CR-UK Trials Unit in Birmingham jointly with the Liverpool Trials Centre.
Registry Information
Official Title
European Study Group for Pancreatic Cancer Trial 1 - Adjuvant Therapy in Operable Pancreatic Cancer
Links & other information
Trial Start Date
02/02/1994
