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

Phase 3RecruitingNCT06467097

Samsung Medical Center88 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Neoplasm

Interventions

SBRT(Stereotatic Body Radiation Therapy)RADIATION

Patients will receive treatment for one to two weeks, one to five times per region.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

1-year progression-free survival rate

Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group

Time frame: One year after completion of enrollment

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Won Park, M.D., Ph.D.

CONTACT

+82-2-3410-2616 wonro.park@samsung.com

Data from ClinicalTrials.gov

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