A trial looking at treatment for children and young people with kidney cancer, including Wilms’ tumour (SIOP WT 2001)

Who can enter

You can enter this trial if you

• Have been diagnosed with kidney cancer, including Wilms’ tumour
• Are aged 0 to 18 years
• Are fit enough to have chemotherapy and to follow the recommended treatment

You will be put into one of two treatment groups (randomisation) to have either 3 chemotherapy drugs or 2 chemotherapy drugs if you

• Have stage 2 or 3 medium risk Wilms' tumour
• Have had the recommended pre-operative (before surgery) chemotherapy on time (your doctor will be able to tell you more about this)
• Are able to start post-operative (after surgery) chemotherapy within 3 weeks of the last dose or pre-operative chemotherapy

Trial design

The treatment you have will depend on the stage of your cancer, and on whether you have low risk, medium risk or high risk Wilms’ tumour. The doctors will look at your Wilms’ tumour cells under a microscope to decide what ‘risk’ it is.

You will have had chemotherapy followed by an operation to remove as much of the cancer as possible. The following information is about the treatment you have after surgery.

Stage 1 Wilms’ tumour

• If you have low risk stage 1 Wilms’ tumour, you will not have any more treatment after surgery
• If you have medium risk stage 1 Wilms’ tumour, you have a short course of dactinomycin (Actinomycin D) and vincristine chemotherapy (AV-1)
• If you have high risk stage 1 Wilms’ tumour, you will have dactinomycin, vincristine and doxorubicin (Adriamycin) chemotherapy (AVD)

Stage 2 and 3 Wilms’ tumour

If you have stage 2 or 3 low risk Wilms’ tumour, you have dactinomycin and vincristine chemotherapy (AV-2).

If you have stage 2 or 3 medium risk Wilms’ tumour, you will be put into one of two treatment groups by a computer. This is called randomisation. Neither you, nor your doctor will be able to decide which group you are in.

• If you are in group 1, you have standard treatment with dactinomycin, vincristine and doxorubicin (AVD)
• If you are in group 2, you have the reduced treatment that is being tested in this trial, this is dactinomycin and vincristine, but no doxorubicin. (AV-2)

If you have stage 2 or 3 high risk Wilms’ tumour, you have etoposide (VP16), carboplatin, cyclophosphamide and doxorubicin (the ‘high risk regimen’). You will also have radiotherapy to your abdomen. All children with stage 3 Wilms' tumour are recommended to have radiotherapy to their abdomen.

Stage 4 Wilms’ tumour

If you have stage 4 Wilms’ tumour, this means the cancer has spread to another part of your body (metastasised). The treatment you have will depend on how well the chemotherapy you had before your operation worked.

• If the chemotherapy worked well, or the cancer spread was completely removed during surgery, you will have dactinomycin, vincristine and doxorubicin chemotherapy (AVD). You also have radiotherapy to your abdomen after chemotherapy

• If your cancer spread did not disappear completely with chemotherapy or could not be removed, you have etoposide (VP16), carboplatin, cyclophosphamide and doxorubicin chemotherapy (the ‘high risk regimen’). You may also have radiotherapy to your abdomen after chemotherapy

• If you have stage 4 high risk Wilms’ tumour and the cancer spread could not be removed with surgery, you have etoposide, carboplatin, cyclophosphamide and doxorubicin chemotherapy (the ‘high risk regimen’). You will then have radiotherapy to your lungs, and possibly radiotherapy to your abdomen.

All stages

You have chemotherapy for between 4 weeks and 8 months depending on what stage and risk your Wilms’ tumour is. Your doctor will tell you in more detail about the treatment you have.

If you have radiotherapy, you have between 8 and 14 treatments (fractions), depending on your age and cancer. Again, your doctor will tell you more about this. You have radiotherapy once a day, Monday to Friday.

The doctors may ask if they can keep a sample of your cancer and a blood sample. If you agree, these samples will be stored and used in future research to help doctors understand more about kidney cancer. You do not have to agree to this part of the trial if you don't want to.

Hospital visits

You will see the doctors and have some tests before taking part in this trial. The tests include

• A biopsy to confirm you have Wilms’ tumour or another type of kidney tumour
• Blood tests
• A physical examination
• An ultrasound of their abdomen
• A chest X-ray
• A heart function test (ECHO)
• Possibly a CT scan

All the chemotherapy drugs in this trial are given through a drip into a vein. If you have the ‘high risk regimen’ you will stay in hospital for chemotherapy. If you have one of the other combinations of chemotherapy, you have your treatment as an out patient. You will also have radiotherapy as an out patient.

After treatment you will see the doctors regularly. How often and for how long will depend on the treatment you have, and on how well the treatment works.

Side effects

All chemotherapy drugs have some side effects. The most common side effects are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Feeling or being sick
• Diarrhoea
• Constipation
• Hair loss
• Reduced fertility

There is more information about the side effects of dactinomycin, vincristine, doxorubicin, carboplatin, cyclophosphamide, etoposide on CancerHelp UK.