A phase 2 feasibility trial comparing chemotherapy or chemoradiotherapy before surgery to surgery on its own for borderline resectable pancreatic cancer (ESPAC-5F)
Full title: ESPAC-5F: Four arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy for patients with borderline resectable adenocarcinoma of the pancreas
Why is this trial being carried out?
Surgery is the standard treatment option for cancer that is contained in the pancreas. Sometimes the cancer may be very close to the major blood vessels that pass under the pancreas, or may even grow into them. Whether the cancer can be removed will depend on how close it is to the blood vessels. This is often called borderline resectable cancer.
The ESPAC-5 trial wants to compare surgery on its own with either chemotherapy before surgery, or chemotherapy and radiotherapy (chemoradiotherapy) before surgery. The aim is to find out which of these options is the most effective in allowing more people to have successful surgery.
This is a phase 2 feasibility study. This means that the trial will start by recruiting a small number of people, to see how many people in each treatment group have their cancer removed.
If you agree to take part in this trial, the treatment group that you are put into is decidedly by computer. This is known as randomisation.
- The first group will have surgery straight away.
- The second group will have GEMCAP (gemcitabine combined with capecitabine) chemotherapy as their first treatment.
- The third group will have FOLFIRINOX chemotherapy as their first treatment.
- The fourth group will have radiotherapy and capecitabine chemotherapy together (chemoradiotherapy) as their first treatment.
With each of the above treatments, the aim is for you to have surgery to remove your cancer.
Who is the trial suitable for?
The ESPAC-5F trial may be suitable for you if you:
- have been diagnosed with borderline resectable cancer
- are able to have a stent inserted into your bile duct
- have satisfactory blood test results – the trial team can discuss this with you
- are well enough for surgery, chemotherapy and radiotherapy.
- have cancer that has spread to other parts of your body (advanced or metastatic cancer)
- have had another type of cancer that was successfully treated and your treatment ended at least three years ago – there may be some exceptions which the trial team can discuss with you
- have had chemotherapy in the last three years – there may be some exceptions which the trial team will discuss with you
- have certain heart problems – the trial team can discuss this with you
- have any other serious medical or psychological condition that might prevent you having chemotherapy, radiotherapy or surgery.
There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial might be suitable for you.
Recruitment start date: August 2014
Recruitment end date: January 2018
Published April 2016
Review date September 2017
The ESPAC-5 trial is being carried out at:
- Royal Liverpool University Hospital, Liverpool
- The Clatterbridge Cancer Centre, Merseyside
- Churchill Hospital, Oxford
- The Royal Marsden NHS Foundation Trust, London and Surrey
- Queen Elizabeth Hospital, Birmingham
- Hammersmith Hospital, London
- The Great Western Hospital, Swindon
- Weston Park, Sheffield
- King’s College Hospital, London
- Guys and St Thomas’s Hospital NHS Foundation Trust, London
- University Hospital Coventry NHS Trust, Coventry
- University Hospital Southampton NHS Foundation Trust, Southampton
- Queen Alexandra Hospital, Hampshire
- Manchester Royal Infirmary, Manchester
- The Christie NHS Foundation Trust, Manchester
- Velindre Cancer Centre, Cardiff
- Morriston and Singleton Hospital, Swansea
- Abertawe Bro Morgannwg University Local Health Board
- Glasgow and the Beatson, Glasgow
- Dundee Ninewells Hospital, Dundee
- Aberdeen Royal Infirmary, Aberdeen
Professor Paula Ghaneh
You can contact the ESPAC-5F trial centre coordinator:
Karen Scott, Cancer Research UK Liverpool Cancer Trials Unit, Liverpool
Telephone: 0151 795 5269
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial please visit the North West Surgical Trials Centre website.
For references used to develop this information please email us.