Comparing treatments for small kidney tumors
Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial
This study is testing whether a new way to destroy small kidney tumors works better and is safer than traditional surgery for people with localized kidney cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06278506 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness and safety of ablative treatments versus surgical resection for small kidney tumors. It will evaluate complications, tumor recurrence, kidney function, quality of life, and health economic factors in patients with localized kidney cancer. Participants will be randomly assigned to receive either treatment, and their outcomes will be monitored to determine which approach is more beneficial. The study addresses a gap in existing research by directly comparing these two treatment modalities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 with a primary kidney tumor measuring 3 cm or less and no signs of metastasis.
Not a fit: Patients with radiological signs of metastasis, synchronous kidney tumors, or high-grade tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with small kidney tumors, potentially reducing complications and enhancing quality of life.
How similar studies have performed: While there have been studies on ablative treatments, this randomized controlled comparison specifically for T1a tumors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Anders Kjellman, MD, PhD — Karolinska University Hospital
- Study coordinator: Anders Kjellman, MD, PhD
- Email: anders.kjellman@regionstockholm.se
- Phone: +46736995258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.