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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- 1-year progression-free survival rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patients aged 20 to 80 years.
- •Patients with individual metastases ≤ 5 cm in longest diameter.
- •Patients with primary tumors surgically removed or scheduled for surgery.
- •Patients histologically diagnosed with clear cell carcinoma.
- •Patients with ECOG performance status 0-
- •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.
- •Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.
- •Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.
- •Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.
- •Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.
排除标准
- •Patients with total bilirubin > 3.6 mg/dL.
- •Patients with AST >160 U/L, ALT > 165 U/L.
- •Patients unable to maintain position for partial nephrectomy radiotherapy.
- •Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.
- •Patients with confirmed brain, peritoneal, or pleural metastases.
- •Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.
- •Patients who do not consent to participate in the study.
- •Pregnant patients.
结局指标
主要结局
1-year progression-free survival rate
时间窗: One year after completion of enrollment
Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group
次要结局
- Local control rate for radiation therapy site at one year(One year after radiation completion of each participant)
- Grade 3 acute adverse event(three to six months after study treatment)
- Grade 3 chronic adverse event(one year to three years after radiation completion)
- 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)
研究者
Won Park
Won Park, M.D., Ph.D.
Samsung Medical Center