Renal CancerROASTNCT03390413
Robot-assisted Surgical Resection vs. Cryoablation of Localised Renal Cancer
A study testing Robot and Cryoablation in people with Renal Cancer, run by Jørgen Bjerggaard Jensen at 1 site in Denmark.
Trial summary
The present study is a randomized clinical trial which investigates robot-assisted partial nephrectomy (RPN) compared to image-guided cryoablation (CA) in a number of functional, oncological and economic variables. Every year close to 1000 Danes are diagnosed with renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Robot and Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 1 Mar 2028
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time biopsy confirmed RCC
- ECOG Performance Status between 0 and 2
- The tumour is found to be eligible for both RPN and CA
- e-GFR> 60 ml/min/1.74 m2
- Written consent after oral and written information has been given
Who cannot join
- Impaired renal function (e-GFR <59 ml/min/1.74m2)
- Previously diagnosed with RCC
- Patients with recognized genetic mutations that directly relate to RCC (eg. Von Hippel Lindau, BHD)
- Allergy to contrast agents
- Pregnancy
- Expected remaining life <12 months
- Active treatment of secondary cancer disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robot-assisted Surgical Resection vs. Cryoablation of Localised Renal Cancer - a Randomised Trial of Functional, Oncological and Financial Aspects
The present study is a randomized clinical trial which investigates robot-assisted partial nephrectomy (RPN) compared to image-guided cryoablation (CA) in a number of functional, oncological and economic variables.
Every year close to 1000 Danes are diagnosed with renal cell carcinoma. Approximately 25% of these newly diagnosed patients have a T1a tumour, thus being candidates to nephron-sparing surgery. Today most nephronsparing surgical procedures consists of RPN, often requiring temporary clamping of the renal artery rendering the kidney to a critical period of warm ischemia which is potentially harmful to the renal function. Image guided ablative modalities has emerged as a minimal-invasive alternative to partial nephrectomy. The level of evidence within this domain is considered to be low as the existing literature is highly influenced by selection bias, and as of yet no randomized trial has compared the two modalities. Especially with the increasing age of the patients, an approach suitable for local anaestesia is desirable.
Read more
Patients from Central Denmark Region and Region of Southern Denmark who are diagnosed with a pT1a renal cell carcinoma that is found to be eligible for both modalities will be offered to enter into a randomized trial to be treated with either RPN og CA. The study's primary endpoint is loss of renal function 6 and 12 month after treatment. Secondary endpoint includes recurrence free survival 1, 3 and 5 years after treatment, readmission and complication rates as well as health economic evaluations.
All patients will be pre- and postoperatively assessed with biochemistry, CT urography, CT thorax and glomerular filtration rate measurements.
Read the detailed description
The diagnosis and management of renal cell carcinoma (RCC) have changed remarkably rapidly. Although the incidence of RCC has been increasing, survival has improved substantially. As incidental diagnosis of small indolent cancers has become more frequent, active surveillance, robot-assisted nephron-sparing surgical techniques and minimally invasive procedures, such as thermal ablation, have gained popularity. Despite progression in cancer control and survival, locally advanced disease and distant metastases are still diagnosed in a notable proportion of patients.
In 2013, RCC was diagnosed in more than 350.000 people worldwide, making it the seventh most common tumour, and this cancer is associated with more than 140.000 deaths per year. Incidence of RCC varies worldwide, being higher in developed countries than in developing countries. In Europe, mortality from RCC peaked at 4.8 per 100.000 in 1990-94 and had declined to 4.1 per 100.000 (-13%) in 2000-04. In the US, 5-year relative survival rates increased from 50% in 1975-77 to 73% in 2003-09. According to the Danish Cancer Registry, approx. 1000 Danes are annually diagnosed with RCC, of which approx. 25% have a small localised tumour that are potentially eligible for a minimal invasive nephron-sparing treatment modality.
With the expansion of routine imaging for many disorders, patients with RCC are increasingly being identified by chance. Only 30% of patients are diagnosed on the basis of symptoms. Small renal masses (SRM) refers to tumours less than 4 cm I diameter, which have not spread beyond the kidney (T1a tumours). The highest incidence of SRM is seen in patients older than 65 years, who generally present themselves with varying degrees of comorbidity. Thus, minimally invasive treatment modalities are highly relevant in the treatment of RCC in the ever-growing elderly population.
Notwithstanding the advances in the understanding of RCC biology, surgery remains the mainstay of curative treatment. Although radical nephrectomy was the standard of care for the management of renal tumours, the detection of SRMs and accumulating evidence that surgical induced chronic kidney disease can increase patients' morbidity have led to more conservative approaches. Specifically, nephron-sparing surgery, ablative modalities and active surveillance. When treating patients with SRM three competing factors must be considered; comorbidity, renal function and oncological outcome. Active surveillance remains controversial as absolute cut-offs for tumour size and growth rate that should prompt intervention are not well defined. In comparison to radical nephrectomy, nephron-sparing surgery has increasingly been used since observations suggested oncological control similar to radical nephrectomy but with the additional benefit of renal preservation and a reduced risk of cardiovascular events. These functional outcomes become important because patients with organ-confined RCC that has been surgical treated are usually long-term survivors (10-years cancer-specific survival of 85-96%). Today most nephron-sparing surgical procedures consists of robot-assisted partial nephrectomy (RPN).
Although surgery still represents the standard of care for RCC, the use of minimally invasive ablative techniques to treat SRMs has been increasing. Ablative treatment such as cryoablation (CA) were initially contemplated only to patients with a single kidney or those deemed unfit to more extensive surgical procedures. Since an increasing number of reports have shown acceptable oncological control and low complications rates the clinical indications for these procedures has been extending. Most studies of outcomes after CA consist of single-institution retrospective reports with low number of un-randomised patients with short follow-up.
Compared to RPN the ablative modalities offer several advantages. Most ablative procedure are now performed as an image-guided procedure on an outpatient basis without the need for surgical intervention. Furthermore, many RPN-procedures requires temporary clamping of the renal artery which renders the kidney to a critical period of warm ischemia.
There exist only very few reports comparing surgical modalities to ablative modalities but a systematic review and meta-analysis of six clinical trials showed that recurrence-free survival and cancer-specific survival were similar for patients treated with surgery or ablation, with less postoperative decline in estimated glomerular filtration rate in the ablation group. The overall complication rate was significantly lower in the ablation group. The existing literature are highly influenced by selection bias and ss of yet no randomised trial has compared RPN to CA.
Since 2015 the treatment of RCC has been located at two centers in Region Midtjylland, Hospitalsenheden Vest Holstebro were RPN are being performed and Aarhus University Hospital were CA are being performed. Both treatment modalities are considered highly expensive with financial costs in the area of dkr. 30.000 to 50.000.
- Conditions
- Renal Cancer
- Being tested
- Robot, Cryoablation
- Keywords
- Cryoablation, Robot-assisted surgical resection
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotProcedure or surgery
Renal cancer treated with robotic surgery
CryoablationProcedure or surgery
Renal cancer treated with cryoablation
| Study group | Role | What they receive |
|---|---|---|
| Robot | Active comparator | Not described Receives: Procedure: Robot |
| Cryo | Experimental | Not described Receives: Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Loss of renal function measured by Chrome-EDTA clearence 6 months post-operatively in each treatment modality
Measured: 6 months
Secondary outcomes (3)
Incomplete ablation
The degree of incomplete ablation 3 months after CA in comparison with the degree of positive surgical margin by robot-assisted resection
Measured: 3 months
Complications
Number of treatment related complications up to 90 days after treatment
Measured: 90 days
Costs
Treatment related costs evaluated by micro costing
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Sep 2019
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2028 (estimated)
Why it stopped: Logistics and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jørgen Bjerggaard Jensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390413
- Sponsor's protocol ID
- UFE-1-10-72-140-17
- Acronym
- ROAST
- Status last verified
- May 2023
- First submitted
- 20 Dec 2017
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitropoulos D, Artibani W, Biyani CS, Bjerggaard Jensen J, Roupret M, Truss M. Validation of the Clavien-Dindo Grading System in Urology by the European Association of Urology Guidelines Ad Hoc Panel. Eur Urol Focus. 2018 Jul;4(4):608-613. doi: 10.1016/j.euf.2017.02.014. Epub 2017 Mar 7.
PubMed 28753862Vind-Kezunovic S, Bouchelouche K, Ipsen P, Hoyer S, Bell C, Bjerggaard Jensen J. Detection of Lymph Node Metastasis in Patients with Bladder Cancer using Maximum Standardised Uptake Value and 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography: Results from a High-volume Centre Including Long-term Follow-up. Eur Urol Focus. 2019 Jan;5(1):90-96. doi: 10.1016/j.euf.2017.06.005. Epub 2017 Jun 23.
PubMed 28753817Nielsen TK, Jensen JB. Efficacy of commercialised extracorporeal shock wave lithotripsy service: a review of 589 renal stones. BMC Urol. 2017 Jul 27;17(1):59. doi: 10.1186/s12894-017-0249-8.
PubMed 28750620
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Surgical Resection vs. Cryoablation of Localised Renal Cancer - a Randomised Trial of Functional, Oncological and Financial Aspects
- ClinicalTrials.gov ID
- NCT03390413
- Acronym / sponsor ID
- ROAST / UFE-1-10-72-140-17
- Conditions
- Renal Cancer
- Keywords
- Cryoablation, Robot-assisted surgical resection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics and lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jørgen Bjerggaard JensenUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 4 Jan 2018 (actual)
- 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 present study is a randomized clinical trial which investigates robot-assisted partial nephrectomy (RPN) compared to image-guided cryoablation (CA) in a number of functional, oncological and economic variables.
Every year close to 1000 Danes are diagnosed with renal cell carcinoma. Approximately 25% of these newly diagnosed patients have a T1a tumour, thus being candidates to nephron-sparing surgery. Today most nephronsparing surgical procedures consists of RPN, often requiring temporary clamping of the renal artery rendering the kidney to a critical period of warm ischemia which is potentially harmful to the renal function. Image guided ablative modalities has emerged as a minimal-invasive alternative to partial nephrectomy. The level of evidence within this domain is considered to be low as the existing literature is highly influenced by selection bias, and as of yet no randomized trial has compared the two modalities. Especially with the increasing age of the patients, an approach suitable for local anaestesia is desirable.
Patients from Central Denmark Region and Region of Southern Denmark who are diagnosed with a pT1a renal cell carcinoma that is found to be eligible for both modalities will be offered to enter into a randomized trial to be treated with either RPN og CA. The study's primary endpoint is loss of renal function 6 and 12 month after treatment. Secondary endpoint includes recurrence free survival 1, 3 and 5 years after treatment, readmission and complication rates as well as health economic evaluations.
All patients will be pre- and postoperatively assessed with biochemistry, CT urography, CT thorax and glomerular filtration rate measurements.
Detailed description
The diagnosis and management of renal cell carcinoma (RCC) have changed remarkably rapidly. Although the incidence of RCC has been increasing, survival has improved substantially. As incidental diagnosis of small indolent cancers has become more frequent, active surveillance, robot-assisted nephron-sparing surgical techniques and minimally invasive procedures, such as thermal ablation, have gained popularity. Despite progression in cancer control and survival, locally advanced disease and distant metastases are still diagnosed in a notable proportion of patients.
In 2013, RCC was diagnosed in more than 350.000 people worldwide, making it the seventh most common tumour, and this cancer is associated with more than 140.000 deaths per year. Incidence of RCC varies worldwide, being higher in developed countries than in developing countries. In Europe, mortality from RCC peaked at 4.8 per 100.000 in 1990-94 and had declined to 4.1 per 100.000 (-13%) in 2000-04. In the US, 5-year relative survival rates increased from 50% in 1975-77 to 73% in 2003-09. According to the Danish Cancer Registry, approx. 1000 Danes are annually diagnosed with RCC, of which approx. 25% have a small localised tumour that are potentially eligible for a minimal invasive nephron-sparing treatment modality.
With the expansion of routine imaging for many disorders, patients with RCC are increasingly being identified by chance. Only 30% of patients are diagnosed on the basis of symptoms. Small renal masses (SRM) refers to tumours less than 4 cm I diameter, which have not spread beyond the kidney (T1a tumours). The highest incidence of SRM is seen in patients older than 65 years, who generally present themselves with varying degrees of comorbidity. Thus, minimally invasive treatment modalities are highly relevant in the treatment of RCC in the ever-growing elderly population.
Notwithstanding the advances in the understanding of RCC biology, surgery remains the mainstay of curative treatment. Although radical nephrectomy was the standard of care for the management of renal tumours, the detection of SRMs and accumulating evidence that surgical induced chronic kidney disease can increase patients' morbidity have led to more conservative approaches. Specifically, nephron-sparing surgery, ablative modalities and active surveillance. When treating patients with SRM three competing factors must be considered; comorbidity, renal function and oncological outcome. Active surveillance remains controversial as absolute cut-offs for tumour size and growth rate that should prompt intervention are not well defined. In comparison to radical nephrectomy, nephron-sparing surgery has increasingly been used since observations suggested oncological control similar to radical nephrectomy but with the additional benefit of renal preservation and a reduced risk of cardiovascular events. These functional outcomes become important because patients with organ-confined RCC that has been surgical treated are usually long-term survivors (10-years cancer-specific survival of 85-96%). Today most nephron-sparing surgical procedures consists of robot-assisted partial nephrectomy (RPN).
Although surgery still represents the standard of care for RCC, the use of minimally invasive ablative techniques to treat SRMs has been increasing. Ablative treatment such as cryoablation (CA) were initially contemplated only to patients with a single kidney or those deemed unfit to more extensive surgical procedures. Since an increasing number of reports have shown acceptable oncological control and low complications rates the clinical indications for these procedures has been extending. Most studies of outcomes after CA consist of single-institution retrospective reports with low number of un-randomised patients with short follow-up.
Compared to RPN the ablative modalities offer several advantages. Most ablative procedure are now performed as an image-guided procedure on an outpatient basis without the need for surgical intervention. Furthermore, many RPN-procedures requires temporary clamping of the renal artery which renders the kidney to a critical period of warm ischemia.
There exist only very few reports comparing surgical modalities to ablative modalities but a systematic review and meta-analysis of six clinical trials showed that recurrence-free survival and cancer-specific survival were similar for patients treated with surgery or ablation, with less postoperative decline in estimated glomerular filtration rate in the ablation group. The overall complication rate was significantly lower in the ablation group. The existing literature are highly influenced by selection bias and ss of yet no randomised trial has compared RPN to CA.
Since 2015 the treatment of RCC has been located at two centers in Region Midtjylland, Hospitalsenheden Vest Holstebro were RPN are being performed and Aarhus University Hospital were CA are being performed. Both treatment modalities are considered highly expensive with financial costs in the area of dkr. 30.000 to 50.000.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot | Active comparator | Procedure: Robot |
| Cryo | Experimental | Procedure: Cryoablation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-time biopsy confirmed RCC
- ECOG Performance Status between 0 and 2
- The tumour is found to be eligible for both RPN and CA
- e-GFR> 60 ml/min/1.74 m2
- Written consent after oral and written information has been given
Key exclusion criteria (7 listed)
- Impaired renal function (e-GFR <59 ml/min/1.74m2)
- Previously diagnosed with RCC
- Patients with recognized genetic mutations that directly relate to RCC (eg. Von Hippel Lindau, BHD)
- Allergy to contrast agents
- Pregnancy
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 |
|---|---|---|
| RobotRenal cancer treated with robotic surgery | Procedure or surgery | Robot |
| CryoablationRenal cancer treated with cryoablation | Procedure or surgery | Cryo |
Primary outcome
Renal function
Time frame: 6 months
Loss of renal function measured by Chrome-EDTA clearence 6 months post-operatively in each treatment modality
3 secondary outcomes
Incomplete ablation
Time frame: 3 months
Complications
Time frame: 90 days
Costs
Time frame: 90 days
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 1 Jun 2023.
- Background: PubMed 28753862Mitropoulos D, Artibani W, Biyani CS, Bjerggaard Jensen J, Roupret M, Truss M. Validation of the Clavien-Dindo Grading System in Urology by the European Association of Urology Guidelines Ad Hoc Panel. Eur Urol Focus. 2018 Jul;4(4):608-613. doi: 10.1016/j.euf.2017.02.014. Epub 2017 Mar 7.
- Background: PubMed 28753817Vind-Kezunovic S, Bouchelouche K, Ipsen P, Hoyer S, Bell C, Bjerggaard Jensen J. Detection of Lymph Node Metastasis in Patients with Bladder Cancer using Maximum Standardised Uptake Value and 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography: Results from a High-volume Centre Including Long-term Follow-up. Eur Urol Focus. 2019 Jan;5(1):90-96. doi: 10.1016/j.euf.2017.06.005. Epub 2017 Jun 23.
- Background: PubMed 28750620Nielsen TK, Jensen JB. Efficacy of commercialised extracorporeal shock wave lithotripsy service: a review of 589 renal stones. BMC Urol. 2017 Jul 27;17(1):59. doi: 10.1186/s12894-017-0249-8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot and Cryoablation in people with Renal Cancer, run by Jørgen Bjerggaard Jensen at 1 site in Denmark.
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: withdrawn, as of the sponsor's last update on 1 Jun 2023. 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 Denmark. 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 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?
Renal function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390413, which also lists 3 linked publications.
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 1 Jun 2023.