ESPAC-3(v2) Trial

Background

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.

Study Design

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, patients must have had a ductal type adenocarcinoma removed from their pancreas and have no evidence that it has spread elsewhere.

Patients with ampullary or other types of pancreas cancer are still eligible for ESPAC-3(v2), but are randomised into three arms as per the original trial design. These patients are allocated to receive chemotherapy (5FU/FA or Gemcitabine) or no additional treatment following their surgery. They are extra to the 1030 target population and will be considered separately when the trial data is analysed.

Hypothesis to be tested

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?

Trial Endpoints

Primary Outcome

• length of survival

Secondary outcomes

• Toxicity
• Quality of life
• 5-year survival

Trial Management

The trial is centrally co-ordinated by the Cancer Research UK Liverpool Cancer Trials Unit (LCTU) and any queries should be directed here (please see contact page)

Click here for an article written by a patient who took part in the Espac-3 trial

A graph below shows the cumulative recruitment for all tumour types on to Espac-3(v2), as of July 2007

References

1. Parkin DM, Muir CS, Whelan SL, Sao Y-T, Ferlay J, in the adjuvant setting Powell J. (Eds). Cancer incidence in five continents. Vol VI. Lyon: International Agency for Research on Cancer 1992 (IARC Scientific Publications No. 120)

2. Neoptolemos JP, Russell RCG, Bramhall S, Theis B for the UK Pancreatic Cancer Group. Low mortality following resection for pancreatic and periampullary tumours in 1026 patients: UK survey of pancreatic specialist units. Br J Surg 1997; 84: 1370-6.

3. Beger HG, Link KH, Poch B, Gansauge F. Pancreatic cancer - recent progress in diagnosis and treatment. In: Neoptolemos JP, Lemoine NR (Eds). Pancreatic Cancer: Molecular and Clinical Advances. Oxford, 1996:227-35.