A study looking at chemotherapy or chemoradiotherapy before surgery for pancreatic cancer (ESPAC-5F)

Cancer type:

Pancreatic cancer

Status:

Open

Phase:

Phase 2

This study is comparing immediate surgery with treatment before surgery for cancer of the pancreas. You may have either chemotherapy or chemotherapy and radiotherapy together before your operation.

The trial is supported by Cancer Research UK.

More about this trial

If you are diagnosed with pancreatic cancer, your specialist will do tests and scans to see if it is likely that you can have surgery to remove your cancer.

If the cancer is very close to (or has grown into) major blood vessels in the pancreas, surgery is more difficult and sometimes it may not be possible to remove the cancer. Researchers want to find out if having other treatments before surgery would mean that more people in this situation can have their cancer completely removed.

In this trial, some people will have surgery as their first treatment, some will have chemotherapy before surgery, and some will have a combination of chemotherapy and radiotherapy (chemoradiotherapy) before surgery.

This is a feasibility study. It will start by recruiting a small number of people with the aims of

  • Seeing if it is possible to recruit people to a trial looking into treatment before surgery for pancreatic cancer
  • Finding out how many people in each treatment group have their cancer removed completely

If the study goes well to begin with, the researchers will increase the numbers of people taking part.

Who can enter

You may be able to join this study if all of the following apply

You cannot join this study if any of these apply. You

  • Have cancer that has spread to another part of your body
  • Have had any other type of cancer apart from successfully treated carcinoma in situ of the cervix or basal cell skin cancer or another type of cancer that has been sucessfully treated and your treatment finished at least 3 years ago
  • Have had chemotherapy in the last 3 years, there may be some exceptions for chemotherapy drugs given for other medical conditions (the trial team can advise you about this)
  • Have had a combination of chemotherapy and radiotherapy
  • Have certain heart problems (the trial team can advise you about this)
  • Have another serious medical condition or mental health problem that the trial team think could affect you taking part
  • Have problems absorbing drugs
  • Are pregnant

Trial design

This phase 2 trial is a feasibility study. The researchers want 100 people to join in the UK and Europe. The people taking part are put into 1 of 4 treatment groups by a computer. Neither you nor your doctor can decide which group you are in. This is called randomisation.

ESPAC-5F trial diagram

If you are in group A, you have surgery within 2 weeks of randomisation.

If you are in group B, you have gemcitabine through a drip into a vein once a week for 3 weeks out of 4. This takes about half an hour each time. And you take capecitabine tablets twice every day, for 3 weeks out of 4. Each 4 week period is called a cycle of treatment.You have 2 cycles of treatment lasting 8 weeks all together.

If you are in group C, you have the drugs folinic acid, 5FU, irinotecan and oxaliplatin through a drip into a vein. This takes about 4 hours. You then have a slow drip of 5FU that takes 46 hours. You have this treatment every 2 weeks for 8 weeks. You will have a thin, flexible tube put into a blood vessel in your chest. This is called a central line. It can stay in place throughout your treatment. You have the slow drip of 5FU via a small pump that is attached to your central line. This means you don’t have to stay in hospital overnight.

If you are in group D, you have radiotherapy once a day (Monday to Friday) for 5½ weeks. And you take capecitabine tablets twice every day during this time.

People in groups B and C have 8 weeks of treatment and a CT scan 2 to 4 weeks after finishing their treatment. People in group D have 6 weeks of treatment and a CT scan 4 to 6 weeks after finishing their treatment. This is to make sure their cancer hasn’t got any bigger and that they can still have surgery.

Whether you have surgery straight away, or after another treatment, the aim will be to remove the cancer if that is possible.

If it is possible to remove the cancer completely, you then have more chemotherapy once you have recovered from the operation. This chemotherapy takes about 6 months. You have one of the following

  • 5FU and folinic acid for 5 days every 4 weeks
  • Gemcitabine once a week for 3 out of every 4 weeks

If your surgeon is not able to remove all of your cancer, your specialist will talk to you about other possible treatments.

Hospital visits

You see the trial team and have some tests before you are put into a treatment group. The tests include

  • Heart trace (ECG)
  • CT scan (if you haven’t had one in the last 4 weeks)
  • Blood tests

The study team will ask for a sample of tissue that is removed if you have surgery. If you have had a biopsy in the past, they will also ask for a sample from that. They want to study as many samples as possible to learn more about why certain people benefit from different types of treatment.  But you don’t have to agree to give these samples for research if you don’t want to. You can still take part in the study.

The number of times you go to hospital will depend on which treatment group you are in.

Everybody taking part will continue to see the trial team for up to a year. During this time, you have a CT scan every 3 months.

The study team will ask you to fill out a questionnaire at 6 of your hospital visits. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Side effects

The common side effects of GemCap chemotherapy include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Tiredness (fatigue)
  • Flu like symptoms such as a high temperature, aching muscles and shivering
  • Soreness, redness and peeling on the palms of your hands and soles of your feet. This is called palmar-plantar syndrome and can cause tingling, numbness and pain
  • Feeling or being sick
  • Diarrhoea

The common side effects of FOLFIRINOX chemotherapy include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Tiredness
  • Feeling or being sick
  • Diarrhoea
  • Hair loss
  • Sore mouth
  • Changes to the way your liver works
  • Brown skin markings
  • Blurred vision, gritty or watery eyes
  • Soreness, redness and peeling on the palms of your hands and soles of your feet
  • Skin rashes

Women may stop having periods during these types of chemotherapy and it can affect both men and women’s ability to have a child afterwards.

The common side effects of radiotherapy include

  • Tiredness
  • Sore skin
  • Poor appetite and weight loss

The common side effects of capecitabine include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Tiredness
  • Diarrhoea
  • Mouth ulcers
  • Feeling or being sick
  • Soreness, redness and peeling on the palms of your hands and soles of your feet

We have more information about what to expect after having surgery for pancreatic cancer.

Location

Aberdeen
Bebington
Birmingham
Cardiff
Coventry
Dundee
Glasgow
Liverpool
London
Manchester
Morriston
Oxford
Portsmouth
Sheffield
Southampton
Sutton
Swindon

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Paula Ghaneh

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Royal Liverpool and Broadgreen University Hospital NHS Trust
University of Liverpool

Other information

This is Cancer Research UK trial number CRUK/12/045.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10559

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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