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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• 1-year progression-free survival rate [Срок оценки: One year after completion of enrollment]

Вторичные конечные точки (4)

• Local control rate for radiation therapy site at one year [Срок оценки: One year after radiation completion of each participant]
• Grade 3 acute adverse event [Срок оценки: three to six months after study treatment]
• Grade 3 chronic adverse event [Срок оценки: one year to three years after radiation completion]
• Overall survival rate [Срок оценки: 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]

Критерии участия

Критерии включения

• 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 0-1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT06467097 · SMC 2023-04-044

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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