Plain English Summary
Background and study aims
There are 12,500 new cases of kidney cancer every year in the UK and it is predicted that this will rise to 16,000 by 2035. The standard treatment for small kidney cancers is surgical removal of the cancer (partial nephrectomy). However, this is a complex surgery procedure and 1 in 20 patients develop complications such as leakage of urine into the abdomen, bleeding and bowel injury. An alternative treatment option is cryoablation, which involves killing cancer cells by freezing. It has fewer complications, faster recovery and gives equally good cancer control. Currently, cryoablation is mainly offered to elderly patients or patients with significant medical problems. It is not clear if it can also benefit other patients. A clinical trial comparing the two options may answer this question. The researchers want to see if patients are willing to be involved in such a trial by conducting a feasibility study first, which if successful will progress to a full trial. The aim of this study is to see whether patients with small renal cancers will take part in a study to compare cancer treatment by cryoablation with partial nephrectomy.
Who can participate?
Patients aged over 18 with small renal cancers
What does the study involve?
Participants are randomly allocated to be treated with cryotherapy or robot-assisted partial nephrectomy (standard care). Cryotherapy involves freezing of the tumour using percutaneous needles. Robot-assisted partial nephrectomy involves surgery to remove the tumour and leave the rest of the kidney behind. Follow-up for the purposes of this study is 6 months, but standard clinical follow up is at least 5 years.
What are the possible benefits and risks of participating?
It is hoped that cryoablation will help participants experience fewer side effects from treatment than if they had a partial nephrectomy, and, because cryoablation is a less invasive treatment, recovery after surgery will be quicker and participants will be able to go back sooner to their normal day to day life. However, this cannot be guaranteed as it is not known what the outcome of the study will be. This is why this study is being conducted and the information gathered from this study will hopefully help doctors to treat future patients diagnosed with a small renal mass better.
Where is the study run from?
Royal Free NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2019 to April 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Maxine Tran
maxine.tran@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Miss Maxine Tran
ORCID ID
http://orcid.org/0000-0002-6034-4433
Contact details
Specialist Centre for Kidney Cancer
Royal Free Hospital
London
NW3 2PQ
United Kingdom
-
maxine.tran@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
40911
Study information
Scientific title
A feasibility study of a cohort embedded randomised controlled trial comparing NEphron-Sparing Treatment (NEST) for small renal masses
Acronym
Study hypothesis
Patients with small renal cancers are willing to enter a treatment trial comparing surgery with cryoablation.
Ethics approval
Approved 05/02/2019, East Midlands - Derby Research Ethics Committee, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, Tel: +44 (0)207 104 8109/(0)207 104 8237, Email: NRESCommittee.EastMidlands-Derby@nhs.net, ref: 19/EM/0004
Study design
Randomised; Both; Design type: Treatment, Surgery, Active Monitoring, Cohort study
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 to request a patient information sheet
Condition
Kidney cancer
Intervention
Randomisation will be performed in blocks of 10 participants through the online system 'Sealed Envelope' (www.sealedenvelope.com) to ensure allocation concealment.
1. Cryotherapy (intervention): Involves the freezing of the tumour by using percutaneous needles.
2. Robot-assisted partial nephrectomy (standard care): involves surgery to remove the tumour and leave the rest of the kidney behind.
Follow-up for the purposes of this feasibility trial will be 6 months, but standard clinical follow up will be at least 5 years.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Recruitment rate, measured using number of participants recruited per month during the study
Secondary outcome measures
1. Retention rate, measured using randomised participants retained and assessed with valid primary outcome data, measured annually
2. Health-related quality of life measured using EQ5D-5L prior to treatment and 3 months following treatment
3. Complications, blood transfusion, ITU admission and renal replacement requirement rates, measured using clinical records during hospital admission, 30 days post-operative and at 6 months
4. Length of hospital stay, time to return to pre-treatment activities, number of work days lost (in those who work), measured using clinical records and follow-up consultation (clinic or telephone) at 30 days and at 6 months
5. Costs incurred by health technologies, measured using NHS reference costs and also private and societal costs measured using patient completed questionnaire at time of treatment, at 30 days and at 6 months
Overall trial start date
29/04/2019
Overall trial end date
28/04/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inclusion criteria for study cohort:
1. Informed consent
2. Males and females
3. > 18 years of age
4. Diagnosed with renal mass <4 cm in size
Inclusion criteria for randomisation/interventional cohort:
1. Biopsy proven RCC
2. Tumours that are suitable for robot-assisted PN and CO
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Participant exclusion criteria
Exclusion criteria for study cohort:
1. Any of the above listed inclusion criteria not met
2. Patient unable to provide or indicate informed consent
Exclusion criteria for randomisation/interventional cohort:
Patients with any concurrent medical/surgical condition or indication, which would mean the SMDT recommends one treatment modality is more suitable than another, such as:
1. Myocardial Infarction in preceding 6/12
2. Pulmonary disease not allowing for prolonged anaesthesia
3. Multiple previous abdominal surgery/interventions, making surgical approach high risk
4. Performance status > = 2
5. Metastatic disease
6. Charlson co-morbidity index > 3
7. Patients with multifocal tumours
8. Patients with suspected or diagnosed with inherited kidney cancer susceptibility syndromes
9. Women that are pregnant or breastfeeding
Recruitment start date
01/05/2019
Recruitment end date
30/06/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Free NHS Foundation Trust
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0817-20013
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Patient and public involvement
An online survey with Kidney Cancer UK (KCUK) involving ninety-nine patients demonstrated their support and need for such a study. The patient representatives helped draft the study protocol, patient information sheets and consent forms. They will represent patient views on the trial management committee, and will have a central role in the design of the full trial and dissemination of study findings.
The protocol is being submitted for publication. The results will be presented at national and international clinical meetings, published in high impact medical journals and communicated to the kidney cancer community through Kidney Cancer UK (KCUK) patient education days, social media and the KCUK and Royal Free Hospital websites.
IPD sharing statement
Anonymised participant level data will be available upon request on a case by case basis, subject to REC approval. Requests can be made to the Chief Investigator. Data will be available not less than 1 year following completion of study and will be available for up to 5 years.
Intention to publish date
28/10/2022
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31189686/ (added 26/06/2020)