A study looking at two different types of surgery for kidney cancer (PARTIAL)
Cancer type:
Status:
Phase:
This study is looking at the side effects of 2 different types of surgery.
It is open to people:
- who have an early stage kidney tumour (up to 7cm)
- and the tumour has not spread outside the kidney
More about this trial
Surgery is the main treatment for early stage kidney cancer (up to 7cm) that has not spread.
There are two different types of surgery:
- removing the whole kidney – this is only possible if you have no problems with your other kidney. It is called a radical nephrectomy.
- removing part of the kidney where the tumour is. This is called a partial nephrectomy.
Researchers don’t know which type of surgery is better for people with this type of cancer. This study will compare the two types of surgery to find out which is better. It will also look at how the financial costs compare for people taking part.
The aims of the study are to find out:
- how well the kidney, or kidneys, work after surgery
- how good the type of surgery is at getting rid of the cancer
- more about side effects of surgery
- how the 2 different surgeries affect
quality of life 
- how much it costs to have either type of surgery. This is both how much it costs the NHS to do the operation. And how much it costs people taking part for things such as travel to the hospital for appointments.
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- have a type of kidney cancer called renal cell cancer
- have recently been diagnosed with kidney cancer that has not spread. Doctors can see what they think is cancer on a scan of your kidney. Or they have found cancer cells in a tissue sample (
biopsy ) from your kidney. - are likely to be suitable for
laparoscopic or robotic surgery (a type of keyhole surgery) to remove part or all of your kidney - have one kidney tumour which is stage T1 (up to 7cm)
- don’t have any problems with your other kidney
- are well enough to have surgery
- have satisfactory blood test results – including kidney function tests
- are at least 18 years old
Who can’t take part
You cannot join study if any of these apply. You:
- only have one kidney that is working well
- have kidney cancer that has spread elsewhere in the body (metastatic cancer)
- have certain changes to your kidney that you were born with (congenital). Your doctor will know which ones.
- have, or your doctors think you might have, inherited kidney cancer syndrome
- are pregnant or breastfeeding
Trial design
It is a randomised study. The study team would like 420 people to take part from the UK.
A computer puts you into 1 of 2 groups. Neither you nor your doctor chooses which group you go into. The groups are:
- Group 1 - removal of the whole kidney
- Group 2 - removal of part of the kidney
Your surgical team arrange for you to have surgery at the hospital.
You have the same care everyone having kidney surgery has. After your surgery the study team look at your notes to see they type of surgery you had. The study team then keep in contact with you for 2 years after surgery. This is to:
- see how you are feeling
- get information about when you have had contact with the NHS
- check your kidney function (you have blood tests as part of your regular NHS care)
- check your remaining kidney on a scan (you have scans around once a year as part of your regular NHS care)
Quality of life
You fill in questionnaires when you join the study and then:
- 1 week after surgery
- 1 month after surgery
- 3 months after surgery
- 6 months after you join the study
- 1 year after you join the study
- 18 months after you join the study
- 2 years after you join the study
The questions ask about:
- your general health and wellbeing
- what you are able to do in your daily life
- side effects
- any visits, appointments or contact with the NHS
These are quality of life questionnaires.
Making decisions about taking part
The team will also ask a small number of people to take part in telephone or in person interviews to find out how they made decisions about taking part in this study. The team will ask you whether you would like to know more about these interviews. You can say no to this and still take part in the main study.
Hospital visits
You don’t have any extra hospital visits while taking part in this study. You have standard NHS care. Your hospital team will explain the surgery to you. Ask them any questions you have.
After your surgery, as part of standard NHS care, you will have regular blood tests to check your kidney function. The study team collect the results of these tests from your medical records. The study team will ask you to have these blood tests done if, for some reason, they are not part of your NHS care. The first one will be done while you are in hospital after your surgery. The team then ask you to have a test at 1 month after your surgery, and then at:
- 6 months after you join the study
- 1 year after you join the study
- 2 years after you join the study
These might be done at the hospital or at your GP surgery.
After surgery, as part of standard NHS care, you are likely to have a kidney every year. The study team collect the results of the scan you have about 2 years after your surgery from your medical records. The study team will not ask you to have scans if your hospital team don’t think you need them.
Side effects
There is a risk of problems or complications after any operation. The possible side effects while taking part in the study are the same as any kidney cancer surgery. Your surgeon will tell you about the potential risks and benefits of each type of surgery.
Possible side effects of kidney cancer surgery include:
- bleeding
- urine leaking
- changes to kidney function
- the cancer not being completely removed
- development of kidney disease
We have more information about kidney cancer surgery.
Location
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
Professor Naeem Soomro
Supported by
NIHR Health Technology Assessment (HTA) programme
Newcastle upon Tyne Hospitals NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
