Resection or Ablation of Small Kidney Tumors (RESTART)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer
• Intervention / Treatment: Procedure: Ablation; Procedure: Surgery

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

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Kjellman, MD, PhD; Phone Number: +46736995258; Email: anders.kjellman@regionstockholm.se
• Study Contact Backup: Name: Per-Olof Lundgren, MD, PhD

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Recruiting
    • Karolinska University Hospital
    • Contact: Anders Kjellman, MD, PhD; Phone Number: +46736995258; Email: anders.kjellman@regionstockholm.se
    • Contact: Per-Olof Lundgren, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation; Ablative treatment of small kidney cancer lesion, could be given with radiofrequency, microwawe or cryoablation	Procedure: Ablation; Microwave ablation, Radiofrequency ablation, Cryo ablation; Other Names: Microwave ablation, Radiofrequency ablation, Cryo ablation
Active Comparator: Partial nephrectomy; Surgical resection with open or laparoscopic technique	Procedure: Surgery; Partial or total nefrectomy; Other Names: Partial nefrectomy, total nefrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Sum of total after all interventions first year after the first intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2, 5 and 10 years after inclusion
Overall survival (OS)	State of survival	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).	One year after inclusion

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Anders Kjellman, MD, PhD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2037

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms
• Other Study ID Numbers: 4612

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No