Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Miss Melinda Jeffels


Contact details

William Leech Building
Framlington Place
Newcastle Upon Tyne
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

A feasibility study for a multicentre randomised controlled trial to compare Surgery (partial nephrectomy) with needle ablation techniques (radiofrequency ablation/cryotherapy) for the treatment of people with small renal masses (4cm)



Study hypothesis

The number of people diagnosed with kidney cancer has doubled over the past 20 years, making it the eight most common cancer in the UK. Most tumours are less than 4cm in size, but over 80% of these are malignant (cancerous) and if left untreated, will slowly grow and spread. Current standard treatment for these small kidney cancers is to remove the diseased part of the kidney in an operation called a partial nephrectomy, but this can be quite a difficult operation. Because of the small tumour size and difficulties with the operation, other treatments have been developed to destroy the tumours. These treatments include radiofrequency ablation, which means that the tumour is destroyed by heat, and cryoablation, which means that the tumour is frozen and destroyed.

Although removing the part of the diseased kidney in an operation is the tried and tested way to treat the kidney cancer, it does have risks and complications, such as bleeding. The other two treatments are less intrusive to the patient, and are less complicated as they do not require such a large operation as having part of the kidney removed, but it is not known if they are as good at destroying all of the tumour, and whether or not patients who have their tumour destroyed with these new methods require further treatment in future.

In this study, we are trying to determine if a large-scale study comparing these treatments is possible which is why this is called a feasibility study. We are also looking at whether patients would be willing to be randomly assigned to a treatment group. The results of this study will then be compared to see how effective each of the treatments were and whether the number of patients who were happy to be randomly assigned to a treatment could be used to determine the number of patients required in a large-scale trial.

Ethics approval

First MREC 09 May 2012 ref: 12/NE/0147

Study design

Randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Renal Cancer; Kidney


Cryoablation, Participants in this study may be randomised to undergo cryoablation as treatment for their small renal mass; Partial Nephrectomy, Participants in this study may be randomised to undergo a partial nephrectomy as treatment for their small renal mass; Radiofrequency ablation, Participants in this study may be randomised to undergo radiofrequency ablation as treatment for their small renal mass; Follow Up Length: 6 month(s)

Intervention type



Not Applicable

Drug names

Primary outcome measures

To estimate the number of patients with a renal mass <4cm who agree to trial randomisation measured at over 18 months of recruitment

Secondary outcome measures

1. Evaluation of treatment of tumour by CT scan and biopsy measured at using CT scans at 1, 3 and 6 months after treatment and renal biopsy at 6 months
2. Qualitative interview responses for after treatment for patients who are eligible measured at eight to sixteen weeks after treatment
3. Qualitative interview responses for patients who decline randomisation measured at two to sixteen weeks after recruitment interaction
4. Quality of Life questionnaire reporting differences measured within 14 days of randomisation, and at 3 months and 6 months follow-up

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age = 18 years
2. ASA physical status classification system of 1 or 2
3. Radiological confirmation of (>20 Hounsfield Unit) enhancing renal mass (< 4cm) or biopsy proven renal cancer
4. CT abdomen/chest/pelvis with no enlarged nodes or distant metastases
5. Patient has provided written informed consent for participation in the study prior to any study specific procedures
6. Target Gender: Male & Female
7. Lower Age Limit 18 years

Participant type


Age group




Target number of participants

Planned Sample Size: 60; UK Sample Size: 60; Description: As this study is open to competitive recruitment, this breakdown of samples size is an estimation

Participant exclusion criteria

1. Coagulopathy
2. Concomitant disease that would render the patient unsuitable for the study
3. Presence of urosepsis
4. Cancer which is completely buried in the kidney
5. More than one small renal cancer mass
6. Previous participation in this study
7. Inability to give informed consent; carer/proxy assent will not be allowed in this study

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

William Leech Building
Newcastle Upon Tyne
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom
+44 191 233 6161

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cancer Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/04/2016: No publications found, study status unverified.