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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

Denmark1 site
  • Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

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 groups in NCT03390413
Study groupRoleWhat they receive
RobotActive comparatorNot described
Receives: Procedure: Robot
CryoExperimentalNot described
Receives: Procedure: Cryoablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. Complications

    Number of treatment related complications up to 90 days after treatment

    Measured: 90 days

  3. 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.

  1. First posted4 Jan 2018
  2. Study start1 Sep 2019
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Why it stopped: Logistics and lack of funding

Resources

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)
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 28753862
  • Vind-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 28753817
  • Nielsen 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

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.

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