A trial looking at chemotherapy after surgery for bladder cancer (NCRI Bladder Trial, EORTC 30994)

Who can enter

You can enter this trial if you

• Have transitional cell bladder cancer
• Have invasive bladder cancer or bladder cancer that has spread to local lymph nodes, but not elsewhere in your body
• Have had an operation to remove your bladder (radical cystectomy) and surrounding lymph nodes
• Are able to start chemotherapy within 3 months of your operation
• Have satisfactory blood results
• Are well enough to take part (performance status 0 or 1)
• Are willing to use adequate contraception if there is a chance that you or your partner could become pregnant

You cannot enter this trial if you

• Have had intravenous chemotherapy or radiotherapy to your bladder before
• Have pure squamous or pure adenocarcinoma bladder cancer
• Are not able to have cisplatin chemotherapy
• Have any medical condition or illness that means you cannot have chemotherapy
• Have had another cancer in the past (apart from non melanoma skin cancer, carcinoma in situ of the cervix or early prostate cancer)
• Are pregnant or breastfeeding - you must have a negative pregnancy test if there is any possibility that you could be pregnant

Trial design

This trial will recruit about 660 patients who have had surgery to remove their bladder (radical cystectomy).

There are two treatment groups in this trial. The trial is randomised. The people taking part are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will start chemotherapy within 3 months of having your operation. You will have either

• MVAC
• High dose MVAC
• Gemcitabine and cisplatin

Your doctor will decide which chemotherapy treatment you have. This will depend on the hospital policy.

MVAC includes the drugs methotraxate, vinblastine, doxorubicin (Adriamycin) and cisplatin. You will have these drugs through a drip for

• 2 days in the first week (days 1 and 2)
• 1 day in the third week (day 15)
• 1 day in the fourth week (day 22)

This is called one cycle of chemotherapy. You will have 4 cycles and so your treatment will take about 4 months in total. High dose MVAC includes the same drugs as above but you have them over a shorter period of time. You will have these drugs through a drip for 2 days of the first week, followed by a week with no chemotherapy. This is called one cycle of chemotherapy. You will have 4 cycles and so your treatment will take about 2 months in total.

You will also have an injection under your skin called a growth factor. These will start in the first week of each cycle and will be given every day for 7 days. This will help your white blood cells to recover more quickly after each treatment.

If you are having gemcitabine and cisplatin you will have these drugs through a drip for

• 2 days of the first week (day 1 and 2)
• 1 day in the second week (day 8)
• 1 day in the third week (day 15)

You will not have chemotherapy in the fourth week. This is called one cycle of chemotherapy. You will have 4 cycles and so your treatment will take about 4 months in total. If you are in group 2, you will not have chemotherapy after your operation. You will see your doctor regularly. You will only have chemotherapy if your cancer comes back. If your cancer comes back, you will have one of the above chemotherapy treatments but you will have six cycles of chemotherapy, rather than four. Your doctor will decide which chemotherapy treatment you have. This will depend on the hospital policy.

Hospital visits

Before you start your treatment a doctor will examine you and do various tests. These may include

• Blood tests
• X-ray, CT scan, MRI scan, or bone scan
• Urine test
• Tests to check that your heart is healthy, including a heart trace (ECG)

Many of these tests will be repeated during and after your treatment. If you are in group 2 you will have a CT scan of your abdomen and pelvis every 3 months in the first year.

If you have chemotherapy, you will stay overnight in hospital for the first night of each cycle. You will probably have the rest of your chemotherapy in the out patients department, so you will be able to go home afterwards.

Because you are taking part in this trial you will have more follow up appointments than patients would normally have. These will be

• Every 3 months for the first year
• Every 6 months for the next 4 years
• Yearly after that

Side effects

All chemotherapy drugs have possible side effects. The most common side effects of MVAC are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Temporary complete hair loss
• Feeling or being sick
• Diarrhoea or constipation
• Loss of appetite
• Dry and sore mouth
• Numbness or tingling in fingers or toes

Your growth factor injections may cause bruising at the injection site.

The most common side effects of gemcitabine and cisplatin are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Feeling or being sick
• Diarrhoea
• Loss of appetite
• Dry and sore mouth
• Tiredness

There is more information about the particular side effects of methotraxate, vinblastine, doxorubicin (Adriamycin), cisplatin and gemcitabine in the cancer drugs section of CancerHelp UK.