A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm)
CONSERVE
CONSERVE: 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)
2 other identifiers
interventional
17
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedDecember 7, 2015
December 1, 2015
2.3 years
May 25, 2012
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of patients who agree to trial registration and accept randomisation
To estimate the proportion of patients with renal masses \< 4cm who agree to trial registration and accept randomisation to either partial nephrectomy or one of the ablative techniques
18 months
Secondary Outcomes (8)
SF-36 quality of life questionnaire
at 7 days of randomisation and at 3 to 6 months follow up
EQ-5D quality of life questionnaire
Within 7 days of randomisation, and at 3 and 6 months follow up
FACT-G quality of life questionnaire
Within 7 days, and 3 and 6 month follow-up
Hospital anxiety and depression questionnaire
Within 7 days, and 3 and 6 month follow up
Differences in results in pre and post treatment CT scans
at 1, 3 and 6 months after surgery
- +3 more secondary outcomes
Study Arms (3)
Partial nephrectomy
OTHERPatients randomised to this arm will undergo a partial nephrectomy
Radiofrequency ablation
OTHERPatients randomised to this arm will undergo radiofrequency ablation
cryoablation
OTHERPatients randomised to this arm will undergo cryoablation
Interventions
Patients will be randomised to receive a partial nephrectomy as treatment for their renal cancer mass
Patients may be randomised to undergo a radiofrequency ablation treatment for their renal cancer mass
Patients may be randomised to undergo cryoablation as treatment for their renal cancer mass
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 18 years
- ASA physical status classification system of 1 or 2
- Radiological confirmation of (\>20 Hounsfield Unit) enhancing renal mass (\< 4cm) or biopsy proven renal cancer
- CT abdomen/chest/pelvis with no enlarged nodes or distant metastases
- Patient has provided written informed consent for participation in the study prior to any study specific procedures
You may not qualify if:
- Coagulopathy
- Concomitant disease that would render the patient unsuitable for the study
- Presence of urosepsis
- Cancer which is completely buried in the kidney
- More than one small renal cancer mass
- Previous participation in this study
- Inability to give informed consent; carer/proxy assent will not be allowed in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trustlead
- Cancer Research UKcollaborator
Study Sites (5)
South Mead Hospital
Bristol, United Kingdom
Gartnavel Hospital
Glasgow, United Kingdom
Guys and St Thomas Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naeem Soomro
Newcastle upon Tyne Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2012
First Posted
May 30, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2014
Study Completion
January 1, 2015
Last Updated
December 7, 2015
Record last verified: 2015-12