Renal CancerCONSERVENCT01608165
A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm)
A study testing Surgical treatment for renal mass, Percutaneous Radiofrequency ablation and Laparascopic or percutaneous cryoablation in people with Renal Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Surgical treatment for renal mass, Percutaneous Radiofrequency ablation and Laparascopic or percutaneous cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jun 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
South Mead Hospital
Bristol
Gartnavel Hospital
Glasgow
Guys and St Thomas Hospital
London
St George's Hospital
London
Freeman Hospital
Newcastle upon Tyne
About this study
Official title: 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)
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.
Read the detailed description
This study will be a multicentre study to determine if it is possible to carry out a future trial comparing the effectiveness of two minimally invasive techniques to remove small kidney cancers, with the standard treatment of removing part of the diseased kidney. In this future study, participants will be randomly assigned (randomised) to one of these three treatment options. This current study will look at whether patients would be willing to be randomised to a treatment type, whether sufficient numbers for a larger trial would be likely to be recruited within a certain time period, and also to decide what aspects of the conduct and outcomes of each of the three treatment types would need to be recorded in a largescale trial to compare their effectiveness.
Eligible participants for this study will be identified and will be invited to take part in the study by their clinicians currently involved in their kidney cancer assessment. They would then receive information about the surgery treatment (removing the diseases part of the kidney) and one of the alternative treatment methods (destroying the kidney cancer tumour using either heat or by freezing) in the participating hospital. If the patient was interested in participating in the study, they will be asked to consent to be randomised to one of the two treatment types they were given the information about.
If a patient declines to be randomised to a treatment, they will be asked to participate in a series of interviews, to establish the reasons behind why they declined, such as if they had a preference for one of the treatments.
Those patients that consent to being randomised to one of the treatment arms will undergo a screening visit to confirm their eligibility for this study, and at this visit they will have a blood sampke taken and be asked to complete some questionnaires about their general health and how they feel. This is so that any questionnaires completed at a later date after treatment will be compared to how the patient responded before treatment, in order to look for any changes or improvements to the patients. Once they have been confirmed as eligible, they will be randomised to a treatment arm,, and a hospital appointment for their treatment will also be made at this time.
At the treatment visit, each patient will be admitted to hospital for their treatment as scheduled, and will be kept in hospital for the recommended duration after their operation. Those having the diseased part of the kidney removed will be kept in hospital for 35 days, those having their kidney cancer frozen using cryoablation will be kept in hospital for 2 days, and those having their kidney cancers destroyed using heat (radiofrequency ablation) will be kept in for one day.
As per standard care, this duration of time in hospital could vary if the patient experiences any unexpected complications. They will also have some blood samples taken at this visit to assess their kidney function.
All treatments will be given by a qualified specialist surgeon with extensive experience in the treatment they are giving the patient.
Three months after their treatment, each patient will be asked to return to their hospital for a followup visit. At this visit, the patients will be asked to complete the same questionnaires as was completed previously, as well as to undertake a CT scan to assess if the treatment they were given was successful and to determine if all the kidney cancer was removed or destroyed. This CT scan is for patients who undergo cryoablaton treatment only. Patients who undergo radiofrequency ablation treatment will have a CT scan one month after treatment. All patients will also have a blood sample taken at this visit to assess their kidney funtion.
Six months after their treatment, each patient will be asked to return to their hospital for a followup visit, at which point patients undergoing cryoablation treatment will once again have a CT scan to assess if their treatment remains a success, and to determine if all the kidney cancer is still destroyed or whether some of it has returned. They will be asked to complete the questionnaires from previous visits one more time, so as to compare how they feel and how their general health has improved or changed from previously.
Patients who undergo radiofrequency ablation treatment or cryoablation treatment will be required to attend for a further final visit within 2 weeks of their 6 month followup visit in order to have a kidney biopsy taken to determine if their treatment remains a success and all of the cancer mass has been destroyed.
After these six months, and five visit, the patient will return to their normal standard clinical followup visits, which they would be having whether they were on the study or not.
As well as these mentioned visits, some patients who consent to be randomised, will also be asked to consent to being involved in a series of interviews, at which times they will be asked general questions on how they feel in general and about the treatments they have received.
- Conditions
- Renal Cancer
- Being tested
- Surgical treatment for renal mass, Percutaneous Radiofrequency ablation, Laparascopic or percutaneous cryoablation
- Keywords
- Small renal cancer mass
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment for renal massProcedure or surgery
Patients will be randomised to receive a partial nephrectomy as treatment for their renal cancer mass
Percutaneous Radiofrequency ablationProcedure or surgery
Patients may be randomised to undergo a radiofrequency ablation treatment for their renal cancer mass
Laparascopic or percutaneous cryoablationProcedure or surgery
Patients may be randomised to undergo cryoablation as treatment for their renal cancer mass
| Study group | Role | What they receive |
|---|---|---|
| Partial nephrectomy | Other | Patients randomised to this arm will undergo a partial nephrectomy Receives: Procedure: Surgical treatment for renal mass |
| Radiofrequency ablation | Other | Patients randomised to this arm will undergo radiofrequency ablation Receives: Procedure: Percutaneous Radiofrequency ablation |
| cryoablation | Other | Patients randomised to this arm will undergo cryoablation Receives: Procedure: Laparascopic or percutaneous cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (8)
SF-36 quality of life questionnaire
To review responses and patients willingness to complete this questionnaire over the course of their involvement in the study
Measured: at 7 days of randomisation and at 3 to 6 months follow up
EQ-5D quality of life questionnaire
To review responses and patient's willingess to complete this questionnaire during the course of their involvement in the study
Measured: Within 7 days of randomisation, and at 3 and 6 months follow up
FACT-G quality of life questionnaire
To review response and patients willingness to complete this questionnaire during the course of their involvement in the study
Measured: Within 7 days, and 3 and 6 month follow-up
Hospital anxiety and depression questionnaire
To review response and patients willingness to complete this questionnaire during the course of their involvement in the study
Measured: Within 7 days, and 3 and 6 month follow up
Differences in results in pre and post treatment CT scans
The timing of these CT scans is dependent on the treatment arm the patient is randomised to.
Measured: at 1, 3 and 6 months after surgery
Effectiveness of treatment by a renal biopsy assessment
This renal biopsy is only applicable to patients undergoing ablative treatment
Measured: 6 months post treatment
Response within qualitative interviews for patients who decline randomisation
Measured: Two to six weeks after recruitment interaction
Response within qualitative interviews following treatment
Measured: Eight to sixteen weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Naeem Soomro, Principal investigator, Newcastle upon Tyne Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608165
- Sponsor's protocol ID
- CRUK/11/036
- Other IDs
- CRUK/11/036, ISRCTN23852951
- Acronym
- CONSERVE
- Status last verified
- Dec 2015
- First submitted
- 25 May 2012
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01608165
- Acronym / sponsor ID
- CONSERVE / CRUK/11/036
- Conditions
- Renal Cancer
- Keywords
- Small renal cancer mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a multicentre study to determine if it is possible to carry out a future trial comparing the effectiveness of two minimally invasive techniques to remove small kidney cancers, with the standard treatment of removing part of the diseased kidney. In this future study, participants will be randomly assigned (randomised) to one of these three treatment options. This current study will look at whether patients would be willing to be randomised to a treatment type, whether sufficient numbers for a larger trial would be likely to be recruited within a certain time period, and also to decide what aspects of the conduct and outcomes of each of the three treatment types would need to be recorded in a largescale trial to compare their effectiveness.
Eligible participants for this study will be identified and will be invited to take part in the study by their clinicians currently involved in their kidney cancer assessment. They would then receive information about the surgery treatment (removing the diseases part of the kidney) and one of the alternative treatment methods (destroying the kidney cancer tumour using either heat or by freezing) in the participating hospital. If the patient was interested in participating in the study, they will be asked to consent to be randomised to one of the two treatment types they were given the information about.
If a patient declines to be randomised to a treatment, they will be asked to participate in a series of interviews, to establish the reasons behind why they declined, such as if they had a preference for one of the treatments.
Those patients that consent to being randomised to one of the treatment arms will undergo a screening visit to confirm their eligibility for this study, and at this visit they will have a blood sampke taken and be asked to complete some questionnaires about their general health and how they feel. This is so that any questionnaires completed at a later date after treatment will be compared to how the patient responded before treatment, in order to look for any changes or improvements to the patients. Once they have been confirmed as eligible, they will be randomised to a treatment arm,, and a hospital appointment for their treatment will also be made at this time.
At the treatment visit, each patient will be admitted to hospital for their treatment as scheduled, and will be kept in hospital for the recommended duration after their operation. Those having the diseased part of the kidney removed will be kept in hospital for 35 days, those having their kidney cancer frozen using cryoablation will be kept in hospital for 2 days, and those having their kidney cancers destroyed using heat (radiofrequency ablation) will be kept in for one day.
As per standard care, this duration of time in hospital could vary if the patient experiences any unexpected complications. They will also have some blood samples taken at this visit to assess their kidney function.
All treatments will be given by a qualified specialist surgeon with extensive experience in the treatment they are giving the patient.
Three months after their treatment, each patient will be asked to return to their hospital for a followup visit. At this visit, the patients will be asked to complete the same questionnaires as was completed previously, as well as to undertake a CT scan to assess if the treatment they were given was successful and to determine if all the kidney cancer was removed or destroyed. This CT scan is for patients who undergo cryoablaton treatment only. Patients who undergo radiofrequency ablation treatment will have a CT scan one month after treatment. All patients will also have a blood sample taken at this visit to assess their kidney funtion.
Six months after their treatment, each patient will be asked to return to their hospital for a followup visit, at which point patients undergoing cryoablation treatment will once again have a CT scan to assess if their treatment remains a success, and to determine if all the kidney cancer is still destroyed or whether some of it has returned. They will be asked to complete the questionnaires from previous visits one more time, so as to compare how they feel and how their general health has improved or changed from previously.
Patients who undergo radiofrequency ablation treatment or cryoablation treatment will be required to attend for a further final visit within 2 weeks of their 6 month followup visit in order to have a kidney biopsy taken to determine if their treatment remains a success and all of the cancer mass has been destroyed.
After these six months, and five visit, the patient will return to their normal standard clinical followup visits, which they would be having whether they were on the study or not.
As well as these mentioned visits, some patients who consent to be randomised, will also be asked to consent to being involved in a series of interviews, at which times they will be asked general questions on how they feel in general and about the treatments they have received.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Partial nephrectomy | Other | Procedure: Surgical treatment for renal massPatients randomised to this arm will undergo a partial nephrectomy |
| Radiofrequency ablation | Other | Procedure: Percutaneous Radiofrequency ablationPatients randomised to this arm will undergo radiofrequency ablation |
| cryoablation | Other | Procedure: Laparascopic or percutaneous cryoablationPatients randomised to this arm will undergo cryoablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatment for renal massPatients will be randomised to receive a partial nephrectomy as treatment for their renal cancer mass | Procedure or surgery | Partial nephrectomy |
| Percutaneous Radiofrequency ablationPatients may be randomised to undergo a radiofrequency ablation treatment for their renal cancer mass | Procedure or surgery | Radiofrequency ablation |
| Laparascopic or percutaneous cryoablationPatients may be randomised to undergo cryoablation as treatment for their renal cancer mass | Procedure or surgery | cryoablation |
Primary outcome
The proportion of patients who agree to trial registration and accept randomisation
Time frame: 18 months
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
8 secondary outcomes
SF-36 quality of life questionnaire
Time frame: at 7 days of randomisation and at 3 to 6 months follow up
EQ-5D quality of life questionnaire
Time frame: Within 7 days of randomisation, and at 3 and 6 months follow up
FACT-G quality of life questionnaire
Time frame: Within 7 days, and 3 and 6 month follow-up
Hospital anxiety and depression questionnaire
Time frame: Within 7 days, and 3 and 6 month follow up
Differences in results in pre and post treatment CT scans
Time frame: at 1, 3 and 6 months after surgery
Effectiveness of treatment by a renal biopsy assessment
Time frame: 6 months post treatment
Response within qualitative interviews for patients who decline randomisation
Time frame: Two to six weeks after recruitment interaction
Response within qualitative interviews following treatment
Time frame: Eight to sixteen weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naeem Soomro principal investigator
Newcastle upon Tyne Hospitals NHS Foundation Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment for renal mass, Percutaneous Radiofrequency ablation and Laparascopic or percutaneous cryoablation in people with Renal Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who agree to trial registration and accept randomisation (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.