Clinical trial NCT06278506: Resection or Ablation of Small Kidney Tumors
Official title: Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Cancer
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief 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. 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.

3. 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.

4. 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

Eligibility criteria: Inclusion Criteria:

* 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
* Absence of radiological signs of metastasis
* Biopsy with malignant pathological analysis (PAD)
* ISUP grade I-III"

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with surgical complications according to Clavien-Dindo grade 2-5
timeFrame: First year after inclusion
measure: Radiological signs of a residual tumor at the 6-month follow-up
timeFrame: 6-month after inclusion
measure: Number of postoperative hospitalization days (LOS)
timeFrame: Sum of total after all interventions first year after the first intervention
Secondary outcomes:
measure: Cancer-specific survival (CSS)
timeFrame: 2, 5 and 10 years after inclusion
measure: Overall survival (OS)
timeFrame: 2, 5 and 10 years after inclusion
measure: Change in eGFR one year after treatment
timeFrame: One year after inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Anders Kjellman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: