Kidney CancerRESTARTNCT06278506
Resection or Ablation of Small Kidney Tumors
A study testing Ablation and Surgery in people with Kidney Cancer, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Ablation and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 31 Jan 2024to Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 - 99 years
- Patient suitable based on clinical status for both ablative treatment and surgery
- Primary kidney tumor
- Tumor size ≤ 3 cm
- Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion)
- Tumor location suitable for both ablative treatment and resection
Show all 9Show fewer
- Absence of radiological signs of metastasis
- Biopsy with malignant pathological analysis (PAD)
- ISUP grade I-III"
Who cannot join
- Radiological signs of metastasis
- Synchronous kidney tumors
- ISUP grade IV or sarcomatoid growth in the biopsy
- Other metastasized cancer in the last 5 years
- Patient unable to make an informed decision to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Per-Olof Lundgren, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Anders Kjellman, MD, PhD, +46736995258, anders.kjellman@regionstockholm.se
Per-Olof Lundgren, MD, PhD
About this study
Official title: Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial
Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.
Read the detailed description
Kidney cancer represents approximately 2-3% of all cancer cases, with about 400,000 new cases and 175,000 deaths worldwide in 2018. In Sweden, about 1,200 new cases of kidney cancer are detected each year. The most common age for diagnosis is between 60 and 80 years, and it is more prevalent in men than in women. Many cases are incidentally discovered during imaging studies for unrelated issues. There has been an increase in incidentally detected tumors in Sweden, from 43% in 2005 to 69% in 2021. Nephron-sparing surgery, i.e., partial nephrectomy, is recommended for preserving kidney function in localized tumors.
Ablative treatments are recommended for patients with significant comorbidities, multiple tumors, a single kidney, or other situations where surgery is not considered suitable. Prior to treatment, a biopsy is usually performed to confirm the diagnosis. Studies show variations in oncological outcomes based on the subgroups of kidney cancer treated with ablative techniques. Ablative techniques seem to have a lower risk of complications compared to surgery concerning perioperative complications, bleeding, and maintaining kidney function for a longer time. However, there are no randomized controlled studies comparing ablative treatment with nephrectomy for T1a tumors in the kidney.
- Hypothesis
Ablative treatment of small kidney tumors may result in shorter hospital stays with fewer complications compared to surgical resection.
There is no difference in long-term oncological outcomes between the methods.
- Outcome Measures
The primary purpose of the study is to compare surgical complications, findings of remaining tumors after primary treatment, and the time patients are hospitalized after each procedure. Secondary outcomes include oncological outcomes in the short and long term, as well as functional factors
- Conditions
- Kidney Cancer
- Being tested
- Ablation, Surgery
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Also called Microwave ablation, Radiofrequency ablation, Cryo ablation
Microwave ablation, Radiofrequency ablation, Cryo ablation
SurgeryProcedure or surgery
Also called Partial nefrectomy, total nefrectomy
Partial or total nefrectomy
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Ablative treatment of small kidney cancer lesion, could be given with radiofrequency, microwawe or cryoablation Receives: Procedure: Ablation |
| Partial nephrectomy | Active comparator | Surgical resection with open or laparoscopic technique Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with surgical complications according to Clavien-Dindo grade 2-5
recorded through chart review at 30 and 90 days after treatment. Complications are summed up in case of retreatment before the 12-month follow-up.
Measured: First year after inclusion
Radiological signs of a residual tumor at the 6-month follow-up
Radiological sign of residual tumor at 6-month radiology
Measured: 6-month after inclusion
Number of postoperative hospitalization days (LOS)
Number of postoperative hospitalization days (LOS), i.e., the time the patient has been hospitalized after the procedure until discharge. Hospitalization time is accumulated in case of retreatment within 12 months.
Measured: Sum of total after all interventions first year after the first intervention
Secondary outcomes (3)
Cancer-specific survival (CSS)
Cancer-specific survival (CSS) is the period from cancer diagnosis to death caused by this cancer diagnosis. CSS will be calculated using Kaplan-Meier estimates and cumulative incidence of cancer-specific death.
Measured: 2, 5 and 10 years after inclusion
Overall survival (OS)
State of survival
Measured: 2, 5 and 10 years after inclusion
Change in eGFR one year after treatment
The study aims to assess kidney function impairment one year after treatment. Blood tests for estimated glomerular filtration rate (eGFR) will be compared with preoperative values to monitor changes. Impaired function is defined as eGFR reduction by ≥20% one year after the procedure compared to measurements before treatment for kidney tumors (10).
Measured: One year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start31 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Kjellman, Karolinska University Hospital
- Investigators
- Anders Kjellman, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278506
- Sponsor's protocol ID
- 4612
- Acronym
- RESTART
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06278506
- Acronym / sponsor ID
- RESTART / 4612
- Conditions
- Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 26 Feb 2024 (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.
Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.
Detailed description
Kidney cancer represents approximately 2-3% of all cancer cases, with about 400,000 new cases and 175,000 deaths worldwide in 2018. In Sweden, about 1,200 new cases of kidney cancer are detected each year. The most common age for diagnosis is between 60 and 80 years, and it is more prevalent in men than in women. Many cases are incidentally discovered during imaging studies for unrelated issues. There has been an increase in incidentally detected tumors in Sweden, from 43% in 2005 to 69% in 2021. Nephron-sparing surgery, i.e., partial nephrectomy, is recommended for preserving kidney function in localized tumors.
Ablative treatments are recommended for patients with significant comorbidities, multiple tumors, a single kidney, or other situations where surgery is not considered suitable. Prior to treatment, a biopsy is usually performed to confirm the diagnosis. Studies show variations in oncological outcomes based on the subgroups of kidney cancer treated with ablative techniques. Ablative techniques seem to have a lower risk of complications compared to surgery concerning perioperative complications, bleeding, and maintaining kidney function for a longer time. However, there are no randomized controlled studies comparing ablative treatment with nephrectomy for T1a tumors in the kidney.
- Hypothesis
Ablative treatment of small kidney tumors may result in shorter hospital stays with fewer complications compared to surgical resection.
There is no difference in long-term oncological outcomes between the methods.
- Outcome Measures
The primary purpose of the study is to compare surgical complications, findings of remaining tumors after primary treatment, and the time patients are hospitalized after each procedure. Secondary outcomes include oncological outcomes in the short and long term, as well as functional factors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Procedure: AblationAblative treatment of small kidney cancer lesion, could be given with radiofrequency, microwawe or cryoablation |
| Partial nephrectomy | Active comparator | Procedure: SurgerySurgical resection with open or laparoscopic technique |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 - 99 years
- Patient suitable based on clinical status for both ablative treatment and surgery
- Primary kidney tumor
- Tumor size ≤ 3 cm
- Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion)
Key exclusion criteria (5 listed)
- Radiological signs of metastasis
- Synchronous kidney tumors
- ISUP grade IV or sarcomatoid growth in the biopsy
- Other metastasized cancer in the last 5 years
- Patient unable to make an informed decision to participate in the study
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 |
|---|---|---|
| AblationAlso: Microwave ablation, Radiofrequency ablation, Cryo ablationMicrowave ablation, Radiofrequency ablation, Cryo ablation | Procedure or surgery | Ablation |
| SurgeryAlso: Partial nefrectomy, total nefrectomyPartial or total nefrectomy | Procedure or surgery | Partial nephrectomy |
Primary outcome
Number of participants with surgical complications according to Clavien-Dindo grade 2-5
Time frame: First year after inclusion
recorded through chart review at 30 and 90 days after treatment. Complications are summed up in case of retreatment before the 12-month follow-up.
Radiological signs of a residual tumor at the 6-month follow-up
Time frame: 6-month after inclusion
Radiological sign of residual tumor at 6-month radiology
Number of postoperative hospitalization days (LOS)
Time frame: Sum of total after all interventions first year after the first intervention
Number of postoperative hospitalization days (LOS), i.e., the time the patient has been hospitalized after the procedure until discharge. Hospitalization time is accumulated in case of retreatment within 12 months.
3 secondary outcomes
Cancer-specific survival (CSS)
Time frame: 2, 5 and 10 years after inclusion
Overall survival (OS)
Time frame: 2, 5 and 10 years after inclusion
Change in eGFR one year after treatment
Time frame: One year after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Per-Olof Lundgren, MD, PhD contact
Anders Kjellman, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation and Surgery in people with Kidney Cancer, run by Karolinska University Hospital at 1 site in Sweden.
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 9 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: looking for participants now, as of the sponsor's last update on 26 Feb 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Kjellman, MD, PhD (+46736995258, anders.kjellman@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with surgical complications according to Clavien-Dindo grade 2-5 (time frame: First year after inclusion). The study lists 3 primary outcomes in all. 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 26 Feb 2024.