Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at chemotherapy for people with advanced cancer of the stomach or food pipe (GO2)
This trial is trying to find the best way to treat people with cancer of the stomach or cancer of the food pipe (oesophagus) who are not strong enough to have standard chemotherapy. The trial is supported by Cancer Research UK.
More about this trial
Doctors often treat
For some people, chemotherapy with 3 drugs is too strong, but a milder form of chemotherapy may still be helpful. For others, it may be best not to have chemotherapy at all, but to have other treatments to control cancer symptoms. This is called best
Some people in the trial will have the drugs at the same doses that are normally used when people have all 3 drugs. So they will be having two thirds of full standard treatment. Other people will have the same drugs but at reduced doses, and some people won’t have any chemotherapy, but will have best supportive care.
The aim of the trial is to work out which treatment is best for frail or elderly people with advanced cancer of the stomach or food pipe.
Who can enter
You may be able to enter this trial if you
advanced cancerof the stomach, the food pipe (oesophagus), or the area where the stomach and oesophagus meet (cancer of the gastro oesophageal junction)
- Are going to have treatment with the aim of controlling the cancer and its symptoms, rather than curing the cancer (you are having
- Are fit enough to have any of the chemotherapy treatments in this trial
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for up to 6 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Are fit enough and willing to have EOX chemotherapy
- Have already had palliative chemotherapy for stomach or oesophageal cancer
- Have problems with your liver or kidneys
- Have any other cancer if your doctor thinks it could affect the outcome of this trial treatment
- Have any other medical condition or mental illness that could affect your taking part
- Are pregnant or breast feeding
This phase 3 trial aims to recruit more than 500 people. Everybody taking part has best supportive care. Most of the people taking part also have chemotherapy.
At the beginning of the trial, your doctor will talk to you about whether or not you are likely to benefit from having chemotherapy. If they think you are, you follow pathway 1 and definitely have chemotherapy. This will include 2 of the 3 standard chemotherapy drugs - either at the full standard dose, or a reduced dose.
But if you and your doctor agree that it is uncertain whether you will benefit from chemotherapy, you follow pathway 2. You may have 2 chemotherapy drugs at a reduced dose, or you may have best supportive care alone.
The trial is randomised, so within each pathway, the treatment you have is decided by a computer. Neither you nor your doctor will be able to decide which treatment you have.
The doctors are looking at 3 different doses of chemotherapy. They are calling these doses levels A, B and C. People following pathway 1 have one of the following 3 treatments
- 2 of the 3 standard drugs (OxCap), at level A
- Level B dose of OxCap
- Level C dose of OxCap
People following pathway 2 have one of the following treatments
- Level C dose of OxCap
- Best supportive care alone
If you have chemotherapy, you have oxaliplatin through a drip into a vein once every 3 weeks. It takes about 2 hours each time. You take capecitabine tablets twice every day. Each 3 week period is called a cycle of treatment.
You have 3 cycles of treatment lasting 9 weeks. Then you have a CT scan and see the trial team.
If you aren’t having bad side effects and the trial doctor can see that the treatment is controlling your cancer, you can carry on having chemotherapy for as long as it helps you. But this is not usually for longer than 6 months.
The trial team will ask you to fill out a questionnaire before you start treatment, and then at different times during and after you have finished treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan
The trial team will also time how long it takes you to walk 3 metres (about 10 feet).
If you have chemotherapy, you go to hospital once every 3 weeks for as long as you continue to have treatment. At each visit, you have blood tests. The trial team will ask you to fill in a questionnaire about how you are feeling each week. This takes about 5 minutes. In the weeks that you don’t go to hospital, a nurse will phone you at home to ask the questions.
After 9 weeks of treatment, you have a CT scan. You also fill in a longer questionnaire about your general health. This takes about 20 minutes. If you continue to have chemotherapy, you have another CT scan after 18 weeks of treatment.
When you finish chemotherapy, you see the trial team every 9 weeks for up to a year. You fill in a 5 minute questionnaire each time.
If you are following pathway 2 and have best supportive care alone, you see the trial team every 9 weeks for up to a year. You may have blood tests.
At the first 2 visits, the trial team will ask you to fill in a 5 minute questionnaire about how you are feeling. If you are not able to go to hospital, the trial team will post the questionnaire to your home. Or a nurse will phone you to ask the questions.
The maximum length of time anybody is involved in the trial is 1 year. After a year, the trial team will continue to check your medical records to see how you are.
The side effects of oxaliplatin include
- Pain in your arm when you have the drip
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- An allergic reaction to the drug - but this is very rare
The side effects of capecitabine include
- Feeling or being sick
- Tiredness (fatigue)
- Sore mouth
- Red, sore or flaky skin, particularly on your hands and feet
We have more information about having oxaliplatin and capecitabine together.
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.
Professor Matt Seymour
Dr Peter Hall
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
St James's University Hospital
University of Leeds
This is Cancer Research UK trial number CRUK/12/022.