Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma (SABLOR)

A Phase Ⅲ Randomized Study Systemic Treatment Alone Versus Systemic Treatment Plus Stereotactic Abative Body Radiotherapy for Patients With Oligometastatic Renal Cell Carcinoma: SABLOR Study

To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

Study Overview

• Status: Recruiting
• Conditions: Kidney Neoplasm
• Intervention / Treatment: Radiation: SBRT(Stereotatic Body Radiation Therapy)

Detailed Description

Various institutions are attempting to use locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, accompanied by a few metastases. Research findings have indicated that high-dose locoregional radiotherapy can suppress disease progression, potentially prolonging the interval for additional systemic therapy; however, whether the addition of locoregional radiotherapy in cases of renal cell carcinoma with oligometastases demonstrates superior oncologic outcome compared to standard systemic therapy alone has yet to be established. Therefore, a randomized phase III study is being conducted to evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Won Park, M.D., Ph.D.; Phone Number: +82-2-3410-2616; Email: wonro.park@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Won Park, M.D., Ph.D.; Phone Number: +82-2-3410-2616; Email: wonro.park@samsung.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases.
2. Patients aged 20 to 80 years.
3. Patients with individual metastases ≤ 5 cm in longest diameter.
4. Patients with primary tumors surgically removed or scheduled for surgery.
5. Patients histologically diagnosed with clear cell carcinoma.
6. Patients with ECOG performance status 0-1.
7. Patients with normal major organ function and bone marrow function meeting specific criteria: WBC ≥ 2,000/μL, neutrophils ≥ 1,000/μL, platelets ≥ 50,000/μL.
8. Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.
9. Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.
10. Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.
11. Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.

Exclusion Criteria:

1. Patients with total bilirubin > 3.6 mg/dL.
2. Patients with AST >160 U/L, ALT > 165 U/L.
3. Patients unable to maintain position for partial nephrectomy radiotherapy.
4. Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.
5. Patients with confirmed brain, peritoneal, or pleural metastases.
6. Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.
7. Patients who do not consent to participate in the study.
8. Pregnant patients.

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
No Intervention: A group; Only standard treatment is administered. The standard treatment includes targeted cancer therapy, immunotherapy, or monotherapy with each therapeutic agent.
Experimental: B group; This group receives concurrent partial nephrectomy radiotherapy for all metastatic lesions in addition to standard treatment.	Radiation: SBRT(Stereotatic Body Radiation Therapy); Patients will receive treatment for one to two weeks, one to five times per region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year progression-free survival rate	Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group	One year after completion of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control rate for radiation therapy site at one year	Compare Local control rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group	One year after radiation completion of each participant
Grade 3 acute adverse event	Compare acute adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group	three to six months after study treatment
Grade 3 chronic adverse event	Compare chronic adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group	one year to three years after radiation completion
Overall survival rate	Compare Overall survival rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): February 13, 2031
• Study Completion (Estimated): February 13, 2031

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: SMC 2023-04-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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