Nephron-sparing treatment for small renal masses
| ISRCTN | ISRCTN18156881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18156881 |
| Secondary identifying numbers | 40911 |
- Submission date
- 18/02/2019
- Registration date
- 04/03/2019
- Last edited
- 16/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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 June 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Maxine Tran
maxine.tran@nhs.net
Contact information
Scientific
Specialist Centre for Kidney Cancer
Royal Free Hospital
London
NW3 2PQ
United Kingdom
 ORCID ID |
0000-0002-6034-4433 |
|---|---|
| maxine.tran@nhs.net |
Study information
| Study design | Randomised; Both; Design type: Treatment, Surgery, Active Monitoring, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A feasibility study of a cohort embedded randomised controlled trial comparing NEphron-Sparing Treatment (NEST) for small renal masses |
| Study objectives | Patients with small renal cancers are willing to enter a treatment trial comparing surgery with cryoablation. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 29/04/2019 |
| Completion date | 17/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Total final enrolment | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 17/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pond Street
London
NW3 2QG
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Free Hospital
Pond Street
London
NW3 2QG
England
United Kingdom
"ROR" |
https://ror.org/04rtdp853 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 28/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/06/2019 | 26/06/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 28/11/2021 to 17/04/2023.
2. The overall trial end date has been changed from 17/06/2022 to 17/06/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 28/10/2022 to 28/10/2023.
4. The target number of participants has been changed from "Planned Sample Size: 200; UK Sample Size: 200" to "Planned Sample Size: 300; UK Sample Size: 300" and the total target enrolment has been changed from 200 to 300.
08/11/2021: The total final enrolment was added.
08/06/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2021 to 28/11/2021.
2. The overall trial end date was changed from 28/04/2022 to 17/06/2022.
26/06/2020: Publication reference added.
20/05/2020: Recruitment resumed.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
22/03/2019: The condition has been changed from “Specialty: Cancer, Primary sub-specialty: Renal Cancer; Health Category: Cancer and neoplasms; Disease/Condition: Malignant neoplasms of urinary tract” to “Kidney cancer” following a request from the NIHR.
