A trial looking at improving chemoradiotherapy for people with cancer of the food pipe (SCOPE 2)

Cancer type:

Oesophageal cancer

Status:

Open

Phase:

Phase 2/3

This trial is looking at a higher than normal dose of radiotherapy and a different type of chemotherapy to treat cancer of the food pipe (oesophagus).  

It is for people with oesophageal cancer:

  • who cannot have surgery
  • having chemotherapy and radiotherapy together (chemoradiotherapy

Cancer Research UK supports this trial. 

More about this trial

Researchers think having a higher dose of radiotherapy may kill more cancer cells. But they need to know for sure that giving a higher dose is better than giving the normal dose.

In this trial people have 1 of the following: 

  • high dose radiotherapy 
  • normal (standard) dose radiotherapy 

Doctors usually give a combination of 2 chemotherapy drugs together with radiotherapy. They often use cisplatin and capecitabine.  

Sometimes, people can’t have capecitabine. In this situation, a drug called fluorouracil is used instead. 

But the standard treatment doesn’t always work. So, doctors want to see if changing to carboplatin and paclitaxel is better in some patients. 

The main aims of this study are to: 

  • find out if having a higher dose of radiotherapy is better at killing cancer cells 
  • find out if changing to carboplatin and paclitaxel is better in some patients 
  • learn about the side effects and how people cope with them 
  • find out how people feel about the new treatment   
  • find out what happens to the chemotherapy in your body
  • find out if it is possible to do a larger study using higher dose radiotherapy and the new chemotherapy combination

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

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

  • You have oesophageal cancer 
  • Your doctors think you are well enough to have chemoradiotherapy to try to cure you cancer
  • Your cancer is within a certain distance from your mouth and stomach (the doctor can tell you more about this) 
  • Your cancer has grown into the surrounding tissues and measures less than 10 cm in diameter (or less than 8 cm if your cancer hasn’t spread) 
  • You have satisfactory blood tests results
  • You have a satisfactory heart rate 
  • Your lungs are working well 
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1
  • You are at least 17 years old
  • You are willing to use reliable contraception during treatment and for 6 months after the final dose of chemoradiotherapy if there is any possibility you or your partner could become pregnant

You cannot join this trial if any of these apply.

  • You have melanoma, lymphoma or sarcoma that started in your oesophagus 
  • You have had treatment for oesophageal cancer or for cancer of the area where the food pipe joins the stomach (gastro oesophageal junction) unless it was for a pre cancer (dysplasia) or for a carcinoma in situ Open a glossary item 
  • Your cancer has spread to a different part of the body (metastasis)
  • You have had another cancer in the last 3 years apart from successfully treated basal cell skin cancer or cancers that have not spread (carcinoma in situ Open a glossary item) of the cervix and breast
  • You have a stent Open a glossary item in your food pipe 
  • You have low levels of an enzyme Open a glossary item called dihydropyrimidine dehydrogenase (DPD)
  • You take drugs for gout (such as allopurinol) or for viral infections (such as aciclovir) and you cannot stop them for the duration of the trial  
  • You have a serious infection Open a glossary item
  • You are known to be sensitive to the chemotherapy drugs used in this trial or anything they contain   
  • You have heart problems such as high blood pressure that isn’t controlled by medication, angina that is not controlled or any other serious heart condition 
  • You have any other serious medical condition that the trial team think could affect you taking part 
  • You are pregnant or breastfeeding 

Trial design

This is a phase 2/3 trial. The researchers need about 584 people from the UK to take part. 

The first day of treatment is called day 1. Everyone has treatment with cisplatin and capecitabine on day 1. 

You have cisplatin as a drip into a vein. It takes between 1 to 4 hours. You may have carboplatin instead if doctors think you can't have cisplatin for any reason. 

You have capecitabine as a tablet. You have it twice a day, every day. You take it for 21 days (this is a treatment cycle).    

On day 14 you might have a PET-CT scan. Your doctor looks at the results of the scan. The treatment you have next depends on these results. Only some hospitals will ask people to have a PET-CT scan. Your doctor can tell you more about this. 

This part of the trial is randomised.     

If your cancer has stayed the same or got worse
You are put into 1 of the following treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in.

  • 1 treatment cycle of carboplatin and paclitaxel. And then 5 weeks of normal dose radiotherapy with chemotherapy every week
  • 3 treatment cycles of cisplatin (or carboplatin) and capecitabine (or fluorouracil). And normal dose radiotherapy in the last 5 weeks 
  • 1 treatment cycle of carboplatin and paclitaxel. And then 5 weeks of high dose radiotherapy with chemotherapy every week
  • 3 treatment cycles of cisplatin (or carboplatin) and capecitabine (or fluorouracil). And high dose radiotherapy in the last 5 weeks

Diagram showing SCOPE2 randomisation

You have carboplatin and paclitaxel through a drip into a vein. The trial team can give you more information on how often you have them.

You have radiotherapy every day, Monday to Friday, with a break at weekends. Each treatment takes about 15 minutes.

If your cancer has got better or you did not have a PET scan 
You are put into 1 of the following treatment groups by computer. Again, neither you nor your doctor will be able to decide which group you are in.

  • 3 treatment cycles of cisplatin (or carboplatin) and capecitabine (or fluorouracil). And normal dose radiotherapy in the last 5 weeks 
  • 3 treatment cycles of cisplatin (or carboplatin) and capecitabine (or fluorouracil). And high dose radiotherapy in the last 5 weeks

Diagram showing SCOPE2 randomisation no PET scan

Quality of life 
Everybody taking part in this trial completes a quality of life questionnaire:

  • before starting treatment
  • at set times during treatment 
  • at set times after treatment

The questionnaire asks about how you have been feeling and what side effects you have had.

Interview study 
The trial team may ask you to take part in an interview study. Only some hospitals will take part in this research.

Researchers need around 40 people that are taking part, or who were invited to take part but declined. You have 2 interviews. 

The trial doctors ask about:

  • your experience on the trial 
  • how you feel about the new treatment 
  • the reasons people might have to not take part in trials 

You have the interviews:

  • after you find out which treatment group you are in 
  • 6 months after the end of treatment.

You do not have to agree to the interview study if you don’t want to. You can still take part in the trial. 

Blood tests
You have 1 extra blood test as part of this trial. The blood test is taken after you finish treatment. 

Tissue samples
The trial team may ask you to use a tissue sample of your cancer taken when you were diagnosed and after your treatment

This is part of the T-SCOPE2 study. You do not have to agree to this research if you don’t want to. You can still take part in the trial. 

Hospital visits

You see a doctor and have some tests before taking part. These tests include: 

  • PET scan 
  • a physical examination
  • heart trace (ECG Open a glossary item) or echocardiogram Open a glossary item if needed 
  • a lung test (spirometry) if needed 
  • blood tests
  • urine test

You also have other tests that are part of your normal care. The doctor can tell you what you need.  

You see the doctor for blood tests and a physical examination every 3 weeks, for the first 6 weeks. And then every week when you start radiotherapy. 

When you finish treatment, you see the trial doctor 3 weeks later. And if you are in the high dose radiotherapy group, you see the doctors:

  • after 6 weeks
  • after 9 weeks 

Everyone sees the doctor every 3 to 4 months for the first 2 years. Then once a year for 3 years.  

Side effects

The trial team monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.  The team will tell you about all the possible side effects before you start the trial.

The most common side effects of radiotherapy are:

  • tiredness and weakness
  • pain when you swallow 
  • difficulty swallowing (dysphasia) 

If you are in the high dose radiotherapy group, you may have more serious side effects. 

We have more information about side effect of radiotherapy for oesophageal cancer

 We also have information about:

Location

Aberdeen
Belfast
Bristol
Cambridge
Canterbury
Cardiff
Cottingham
Coventry
Derby
Glasgow
Gloucester
Inverness
Leeds
London
Manchester
Middlesbrough
Newcastle upon Tyne
Oxford
Peterborough
Rhyl
Sheffield
Southampton
Sutton
Swansea
Wirral
Worcester
Wrexham

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

Dr Thomas Crosby

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
Velindre NHS Trust

Other information

This is Cancer Research UK trial number CRUK/14/022.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12651

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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