"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at how capecitabine works in people with stomach cancer after having their stomach removed
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Stomach cancer
Status:
Closed
Phase:
Phase 4
This study is to find out how capecitabine works in people with stomach cancer who have had all of their stomach removed (total gastrectomy).
Doctors often treat stomach cancer with chemotherapy and surgery. The combination of chemotherapy drugs that doctors use is epirubicin, cisplatin and capecitabine (ECX).
Capecitabine is a tablet. For it to work properly, the body must be able to take it in. This happens in the gut.
The aim of this study is to find out how much capecitabine is absorbed into the body of people who have had all of their stomach removed.
Who can enter
You can enter this trial if you
- Have the most common type of stomach cancer (adenocarcinoma)
- Are having surgery to remove all of your stomach (total gastrectomy)
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1, 2)
- Are willing to use reliable contraception, for 4 weeks before and 6 weeks after the study, if there is a chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have stomach cancer that has spread to other body organs or other parts of the body (stage 4)
- Have a build up of fluid in your tummy area (abdomen) that is caused by your cancer - doctors call this malignant ascites
- Have problems taking tablets
- Have a serious heart disease
- Are having any chemotherapy drugs other than ECX
- Have had serious side effects from chemotherapy drugs similar to capecitabine like 5 fluorouracil (5FU)
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have another medical problem that could affect you taking part
- Are pregnant or breastfeeding
Trial design
This is a phase 4 study. It will recruit 12 people at 2 hospitals in the UK. Everyone taking part will have chemotherapy before and after having their stomach removed. The chemotherapy is a combination of epirubicin, cisplatin and capecitabine (ECX).
You have epirubicin and cisplatin as a drip into a vein (intravenous injection) every 3 weeks.
Capecitabine is a tablet you take at home; starting on the same day you have the epirubicin and cisplatin. You take the tablets twice a day everyday for 3 weeks.
Each 3 weeks is called a cycle of treatment.
After 3 cycles of treatment, you have surgery to remove your stomach (total gastrectomy).
After surgery you see the doctor to discuss whether you should continue to have chemotherapy.
Hospital visits
You see the doctor and have some tests before taking part in this trial. These tests include
- Physical examination
- Heart trace (
ECG 
) - Urine test
- Blood test
- CT scan
- Chest X-ray (if the CT scan does not include the chest)
Before cycles 2 and 3 you see the doctor and have blood tests.
Before surgery you see the doctor and have a CT scan of your tummy (abdomen) and chest. Or you may have a CT scan of the abdomen and a chest X-ray.
You start having chemotherapy again within 10 weeks of having surgery. Before starting chemotherapy, you see the doctor and have the following tests
- Physical examination
- Heart trace (ECG)
- Blood tests
Before cycles 5 and 6 you have a blood test and urine test.
You see the doctor 1 month after finishing chemotherapy.
Side effects
Al treatments have side effects the most common side effects of epirubicin, cisplatin and capecitabine (ECX) are
- A drop in blood cells causing an increased risk of infection, bleeding and bruising
- Sore mouth and mouth ulcers
- Diarrhoea
- Soreness, redness and peeling of the skin on the palms and soles of the feet (palmar-plantar syndrome)
- Feeling or being sick
- Changes in taste
- Hair loss
- Tiredness (fatigue)
- Loss of appetite
You can find more about epirubicin, cisplatin, capecitabine and ECX on CancerHelp UK.
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
Prof Duncan Jodrell
Supported by
Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
Roche
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Oracle 6011
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
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