Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney CancER (STROKER): A Multicenter, Randomized Controlled Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 9
- 主要终点
- Progression free survival
研究概览
简要总结
This phase III randomized controlled trial evaluates the efficacy of stereotactic body radiation therapy (SBRT) in oligometastatic renal cell carcinoma. The study aims to determine if the addition of SBRT to standard systemic therapy prolong survival compared to the standard systemic therapy alone. In addition, the study will explore the impact of this combined modality therapy on patients' toxicity and quality of life. The researchers will compare SBRT plus standard systemic therapy to standard systemic therapy alone, which is targeted agents and immunotherapy in this case, to determine if SBRT could prolong survival.
详细描述
PRIMARY OBJECTIVES:
To compare the progression-free survival (PFS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.
SECONDARY OBJECTIVES:
I. To compare the overall survival (OS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.
II. To compare the cancer specific survival (CSS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of renal cell carcinoma of any histology
- •Age ≥ 18 years.
- •ECOG performance status of 0-
- •Imaging suggests the presence of distant metastases, with no more than 5 metastatic lesions according to RECIST 1.1 criteria and MDA standards.
- •The patient has received local therapy to primary site, including surgery, stereotactic radiotherapy, or ablation.
- •The patient has received no more than 2 lines of systemic therapy.
- •No significant impairment of major organ function:
- •Hemoglobin (HB) ≥ 80 g/L Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelets (PLT) ≥ 75 × 10⁹/L Serum total bilirubin ≤ 1.5 × ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
排除标准
- •Presence of intracranial metastases.
- •Target lesions have previously received high-dose irradiation with .
- •Target lesions are unsuitable for radiation therapy judged by treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or penetrating the bronchus).
- •Uncontrollable metastatic pleural effusion or ascites.
- •Presence of other malignancies that have not been cured.
- •History of significant psychiatric disorders that impede understanding of informed consent and compliance with the study protocol.
- •Presence of other serious illnesses that may pose significant risks or affect radiation therapy.
- •Women who are pregnant, breastfeeding, or with plans for childbearing during the study.
- •Any other reasons deemed by the investigator to make the subject unsuitable for participation in the study.
研究组 & 干预措施
SBRT arm
Patients undergo SBRT to all metastatic sites in addition to standard systemic therapy. Patients should complete radiotherapy for all lesions within 6 months of enrollment, preferably within the first 3 months.
干预措施: Stereotactic body radiotherapy (SBRT) (Radiation)
SBRT arm
Patients undergo SBRT to all metastatic sites in addition to standard systemic therapy. Patients should complete radiotherapy for all lesions within 6 months of enrollment, preferably within the first 3 months.
干预措施: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib (Drug)
Control arm
Patients receive standard systemic therapy.
干预措施: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib (Drug)
结局指标
主要结局
Progression free survival
时间窗: From enrollment to disease progression, up to 5 years
the time from randomization to the first occurrence of tumor progression or death. If no progression occurs, PFS is measured up to the date of the last follow-up.
次要结局
- Overall survival(From enrollment to death from any cause, up to 5 years)
- Cancer specific survival(From enrollment to death from cancer, up to 5 years)
- Local control rate(From enrollment to in-field progression, up to 5 years)
- Progression-free survival 2(From the initiation of systemic treatment to disease progression, up to 5 years)
- Post-treatment progression free survival(From the initiation of systemic treatment to disease progression, up to 5 years)
- Health-related quality of life by EQ-5D-5L(Up to 2 years)
- Incidence of Adverse Events(Up to 2 years)
- Patient-Reported Adverse Events(Up to 2 years)
- Health-related quality of life by FSKI(Up to 2 years)
研究者
ZHOU FANGJIAN
Principal Investigator
Sun Yat-sen University