Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma

Kidney Neoplasm Clinical Trial

— SABLOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467097
• Other study ID #: SMC 2023-04-044
• Status: Recruiting
• Phase: Phase 3
• Start date: April 16, 2024
• Est. completion date: February 13, 2031

Study information

• Verified date: June 2024
• Source: Samsung Medical Center
• Contact: Won Park, M.D., Ph.D.
• Phone: +82-2-3410-2616
• Email: wonro.park[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: February 13, 2031
• Est. primary completion date: February 13, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasm
• Kidney Neoplasms

Intervention

Radiation:
• SBRT(Stereotatic Body Radiation Therapy)
Patients will receive treatment for one to two weeks, one to five times per region.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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