Condition category
Cancer
Date applied
24/05/2012
Date assigned
24/05/2012
Last edited
20/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Melinda Jeffels

ORCID ID

Contact details

William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
-
info@isrctn.com

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 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

15/06/2012

Overall trial end date

15/12/2013

Reason abandoned

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
+44 191 233 6161
webmaster@rmpd.org.uk

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

Cancer Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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.