Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01608165
Protocol/serial number
12184
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)
Acronym
CONSERVE
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Renal Cancer; Kidney
Intervention
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
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
15/06/2012
Overall trial end date
15/12/2013
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
15/06/2012
Recruitment end date
15/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 233 6161
webmaster@rmpd.org.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
Basic results (scientific)
Publication list