Clinical trial NCT06467097: Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Kidney Neoplasm
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Control group: A group that undergoes standard treatment alone for metastatic renal cell carcinoma.
2. Experimental group: A group that receives concurrent radiotherapy for all metastatic lesions in addition to standard treatment.

We will compare the one-year progression-free survival rate between these groups, randomized from a random allocation point. Block randomization will be used, with 44 participants randomly assigned to each group using a random number table generated from a web-based program.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1-year progression-free survival rate
timeFrame: One year after completion of enrollment
Secondary outcomes:
measure: Local control rate for radiation therapy site at one year
timeFrame: One year after radiation completion of each participant
measure: Grade 3 acute adverse event
timeFrame: three to six months after study treatment
measure: Grade 3 chronic adverse event
timeFrame: one year to three years after radiation completion
measure: Overall survival rate
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: