A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm) (CONSERVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Mr Naeem Soomro, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01608165
First received: May 25, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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 Intervention
Renal Cancer
Procedure: Surgical treatment for renal mass
Procedure: Percutaneous Radiofrequency ablation
Procedure: Laparascopic or percutaneous cryoablation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • The proportion of patients who agree to trial registration and accept randomisation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • SF-36 quality of life questionnaire [ Time Frame: at 7 days of randomisation and at 3 to 6 months follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Response within qualitative interviews following treatment [ Time Frame: Eight to sixteen weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Partial nephrectomy
Patients randomised to this arm will undergo a partial nephrectomy
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
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
Procedure: Laparascopic or percutaneous cryoablation
Patients may be randomised to undergo cryoablation as treatment for their renal cancer mass

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608165

Contacts
Contact: Naeem Soomro 0191 213 7597 naeem.soomro@nuth.nhs.uk
Contact: Melinda Jeffels 0191 222 7249 melinda.jeffels@newcastle.ac.uk

Locations
United Kingdom
South Mead Hospital Recruiting
Bristol, United Kingdom
Contact: Frank Keeley       fimio@blueyonder.co.uk   
Principal Investigator: Frank Keeley         
Gartnavel Hospital Recruiting
Glasgow, United Kingdom
Contact: Grenville Oades       grenville.oades@ggc.scot.nhs.uk   
Principal Investigator: Grenville Oades         
Guys and St Thomas Hospital Not yet recruiting
London, United Kingdom
Contact: Tim O'Brien       tim.obrien@gstt.nhs.uk   
Principal Investigator: John Peters         
St George's Hospital Recruiting
London, United Kingdom
Contact: Chris Anderson       cja@blueyonder.co.uk   
Principal Investigator: Chris Anderson         
Freeman Hospital Recruiting
Newcastle upon Tyne, United Kingdom
Contact: David Rix       david.rix@nuth.nhs.uk   
Principal Investigator: David Rix         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Cancer Research UK
Investigators
Principal Investigator: Naeem Soomro Newcastle upon Tyne Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Mr Naeem Soomro, Consultant Urologist/ Honorary Clinical Senior Lecturer, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01608165     History of Changes
Other Study ID Numbers: CRUK/11/036, CRUK/11/036, ISRCTN23852951
Study First Received: May 25, 2012
Last Updated: June 24, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Small renal cancer mass

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014