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

Phase 3

Recruiting

• Conditions: Kidney Neoplasm
• Interventions: Radiation: SBRT(Stereotatic Body Radiation Therapy)

• Registration Number: NCT06467097
• Lead Sponsor: Samsung Medical Center

Brief 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.

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 Timeline

• Study Start: 2024-04-16
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Primary Completion: 2031-02-13
• Study Completion: 2031-02-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B group	SBRT(Stereotatic Body Radiation Therapy)	This group receives concurrent partial nephrectomy radiotherapy for all metastatic lesions in addition to standard treatment.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Local control rate for radiation therapy site at one year	One year after radiation completion of each participant	Compare Local control rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Grade 3 acute adverse event	three to six months after study treatment	Compare acute adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Grade 3 chronic adverse event	one year to three years after radiation completion	Compare chronic adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
Overall survival rate	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	Compare Overall survival rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of