A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm)

Summary

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, the investigators are trying to determine if a large-scale study comparing these treatments is possible which is why this is called a feasibility study. The investigators 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.

Conditions

• Renal Cancer

Interventions

PROCEDURE

Surgical treatment for renal mass

Patients will be randomised to receive a partial nephrectomy as treatment for their renal cancer mass

PROCEDURE

Percutaneous Radiofrequency ablation

Patients may be randomised to undergo a radiofrequency ablation treatment for their renal cancer mass

PROCEDURE

Laparascopic or percutaneous cryoablation

Patients may be randomised to undergo cryoablation as treatment for their renal cancer mass

Sponsors & Collaborators

• Cancer Research UK

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Naeem Soomro · Newcastle upon Tyne Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2014-10-31

Completion

2015-01-31

Countries

• United Kingdom

Study Locations