A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm) (CONSERVE)
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ClinicalTrials.gov Identifier: NCT01608165 |
Recruitment Status :
Completed
First Posted : May 30, 2012
Last Update Posted : December 7, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Cancer | Procedure: Surgical treatment for renal mass Procedure: Percutaneous Radiofrequency ablation Procedure: Laparascopic or percutaneous cryoablation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
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) |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | January 2015 |
Arm | Intervention/treatment |
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Partial nephrectomy
Patients randomised to this arm will undergo a partial nephrectomy
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Procedure: Surgical treatment for renal mass
Patients will be randomised to receive a partial nephrectomy as treatment for their renal cancer mass |
Radiofrequency ablation
Patients randomised to this arm will undergo radiofrequency ablation
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Procedure: Percutaneous Radiofrequency ablation
Patients may be randomised to undergo a radiofrequency ablation treatment for their renal cancer mass |
cryoablation
Patients randomised to this arm will undergo cryoablation
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Procedure: Laparascopic or percutaneous cryoablation
Patients may be randomised to undergo cryoablation as treatment for their renal cancer mass |
- 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
- SF-36 quality of life questionnaire [ Time Frame: at 7 days of randomisation and at 3 to 6 months follow up ]To review responses and patients willingness to complete this questionnaire over the course of their involvement in the study
- EQ-5D quality of life questionnaire [ Time Frame: Within 7 days of randomisation, and at 3 and 6 months follow up ]To review responses and patient's willingess to complete this questionnaire during the course of their involvement in the study
- FACT-G quality of life questionnaire [ Time Frame: Within 7 days, and 3 and 6 month follow-up ]To review response and patients willingness to complete this questionnaire during the course of their involvement in the study
- Hospital anxiety and depression questionnaire [ Time Frame: Within 7 days, and 3 and 6 month follow up ]To review response and patients willingness to complete this questionnaire during the course of their involvement in the study
- Differences in results in pre and post treatment CT scans [ Time Frame: at 1, 3 and 6 months after surgery ]The timing of these CT scans is dependent on the treatment arm the patient is randomised to.
- Effectiveness of treatment by a renal biopsy assessment [ Time Frame: 6 months post treatment ]This renal biopsy is only applicable to patients undergoing ablative 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 ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608165
United Kingdom | |
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 |
Principal Investigator: | Naeem Soomro | Newcastle upon Tyne Hospitals NHS Foundation Trust |
Responsible Party: | Newcastle-upon-Tyne Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT01608165 |
Other Study ID Numbers: |
CRUK/11/036 CRUK/11/036 ( Other Grant/Funding Number: Cancer research UK ) ISRCTN23852951 ( Registry Identifier: ISRCTN ) |
First Posted: | May 30, 2012 Key Record Dates |
Last Update Posted: | December 7, 2015 |
Last Verified: | December 2015 |
Small renal cancer mass |
Kidney Neoplasms Carcinoma, Renal Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Kidney Diseases Urologic Diseases Male Urogenital Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |