A trial looking at improving chemoradiotherapy for people with cancer of the food pipe (SCOPE 2)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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 13 cm in diameter (or less than 10 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 
- Your cancer has spread to a different part of the body (metastasis)
- You have or have had another cancer that doctors think could cause you significant problems over the next 3 years
- You have a
stent in your food pipe - You have low levels of an
enzyme 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 and doctors think that you can't have chemotherapy
- 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
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
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 ) or echocardiogram 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:
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.
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.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
