Renal CancersPhase 2NCT00922948
Cryoablation Versus Radiofrequency Ablation for Small Renal Masses
A Phase 2 study testing Cryoablation and Radiofrequency ablation in people with Renal Cancers, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Cancers
- What is being tested?
- Cryoablation and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Mar 2015
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with tumors that progress in size while on a watchful waiting protocol;
- Patients with multiple tumors;
- Patients with a tumor in a solitary kidney;
- Patients with poor renal function and a renal tumor;
- Patients with significant co-morbidities that may benefit from a less invasive approach.
Who cannot join
- Large tumors > 4.0cm;
- Unable to have a general anesthetic;
- Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy);
- Uncorrectable bleeding diathesis;
- Evidence of metastatic disease.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
About this study
Official title: A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.
Read the detailed description
By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.
- Conditions
- Renal Cancers
- Being tested
- Cryoablation, Radiofrequency ablation
- Keywords
- Radiofrequency ablation, Cryosurgery, Renal cancers
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.
Radiofrequency ablationProcedure or surgery
Thermal injury is the predominant mechanism of action of RFA. A high-frequency alternating current emitted from the exposed noninsulated portion of the electrode generates frictional heat, agitating ions in the tissue surrounding the tip of the needle.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Not described Receives: Procedure: Cryoablation |
| Radiofrequency ablation | Active comparator | Radiofrequency ablation Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate.
Measured: Baseline, Weeks 6, 12, 24, 36, 48
Secondary outcomes (4)
Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.
Measured: Baseline, Weeks 6, 12, 24, 36 and 48
Average percentage decrease in tumor size.
Measured: Baseline, Weeks 6, 12, 24, 36 and 48
Intra and post-operative complications rates.
Measured: Weeks 6, 12, 24, 36 and 48
Quality of life data.
Measured: Baseline, Weeks 6, 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Cryoablation is no longer offered at our hospital, and likely won't be offered in the near future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Kapoor, St. Joseph's Healthcare Hamilton
- Investigators
- Anil Kapoor, MD, Principal investigator, McMaster Institute of Urology, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922948
- Sponsor's protocol ID
- IIS-001-09
- Status last verified
- Jul 2016
- First submitted
- 16 Jun 2009
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
- ClinicalTrials.gov ID
- NCT00922948
- Acronym / sponsor ID
- IIS-001-09
- Conditions
- Renal Cancers
- Keywords
- Radiofrequency ablation, Cryosurgery, Renal cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cryoablation is no longer offered at our hospital, and likely won't be offered in the near future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jun 2009 (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 purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.
Detailed description
By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Procedure: Cryoablation |
| Radiofrequency ablation | Active comparator | Procedure: Radiofrequency ablationRadiofrequency ablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with tumors that progress in size while on a watchful waiting protocol;
- Patients with multiple tumors;
- Patients with a tumor in a solitary kidney;
- Patients with poor renal function and a renal tumor;
- Patients with significant co-morbidities that may benefit from a less invasive approach.
Key exclusion criteria (5 listed)
- Large tumors > 4.0cm;
- Unable to have a general anesthetic;
- Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy);
- Uncorrectable bleeding diathesis;
- Evidence of metastatic disease.
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 |
|---|---|---|
| CryoablationCryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance. | Procedure or surgery | Cryoablation |
| Radiofrequency ablationThermal injury is the predominant mechanism of action of RFA. A high-frequency alternating current emitted from the exposed noninsulated portion of the electrode generates frictional heat, agitating ions in the tissue surrounding the tip of the needle. | Procedure or surgery | Radiofrequency ablation |
Primary outcome
Treatment failure rate.
Time frame: Baseline, Weeks 6, 12, 24, 36, 48
4 secondary outcomes
Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.
Time frame: Baseline, Weeks 6, 12, 24, 36 and 48
Average percentage decrease in tumor size.
Time frame: Baseline, Weeks 6, 12, 24, 36 and 48
Intra and post-operative complications rates.
Time frame: Weeks 6, 12, 24, 36 and 48
Quality of life data.
Time frame: Baseline, Weeks 6, 12, 24, 36 and 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
Related trials for Renal Cancers
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
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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.
Anil Kapoor, MD principal investigator
McMaster Institute of Urology, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryoablation and Radiofrequency ablation in people with Renal Cancers, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 5 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: withdrawn, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Treatment failure rate. (time frame: Baseline, Weeks 6, 12, 24, 36, 48). 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 27 Jul 2016.