Actively Recruiting
Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney Cancer A Multicenter Randomized Controlled Trial
Led by Sun Yat-sen University · Updated on 2026-01-15
252
Participants Needed
9
Research Sites
156 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of stereotactic body radiation therapy (SBRT) combined with standard systemic therapy for people with oligometastatic renal cell carcinoma, a form of kidney cancer with limited spread. This phase III randomized controlled trial compares whether adding SBRT to targeted agents and immunotherapy can prolong survival and affect quality of life and treatment side effects, compared to systemic therapy alone. The study also explores cancer progression, survival rates, and patient-reported outcomes. Participants are randomly assigned to one of two groups: one group receives standard systemic therapy alone, and the other group receives SBRT targeted to all metastatic sites in addition to the same systemic therapy. The SBRT is delivered with a dose schedule determined by the treating radiation oncologist, aiming for a biologically effective dose of at least 115, and treatment to all lesions is ideally completed within 3 to 6 months after enrollment. Systemic therapies include drugs like axitinib, lenvatinib, cabozantinib, sunitinib, and pazopanib, with or without immune checkpoint inhibitors. Throughout the trial, participants undergo imaging tests such as CT, PET/CT, and MRI scans to monitor cancer progression. Researchers measure progression-free survival from enrollment up to five years, along with overall survival, cancer-specific survival, local tumor control, and treatment-related toxicities over up to two years. Quality of life is assessed using questionnaires at regular intervals. The entire study duration can last up to five years to gather comprehensive data on treatment effects and safety.
CONDITIONS
Brief Title
Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of renal cell carcinoma of any histology
- Age 18 years or older
- ECOG performance status of 0-2
- Imaging shows no more than 5 distant metastatic lesions
- Prior local therapy to primary site including surgery, stereotactic radiotherapy, or ablation
- No more than 2 prior lines of systemic therapy
- Adequate major organ function including hemoglobin 6 80 g/L, neutrophils 6 1.5 x 10^9/L, platelets 6 75 x 10^9/L, bilirubin 4 1.5 x upper limit normal, ALT and AST 4 3 x upper limit normal, and coagulation times 4 1.5 x upper limit normal
You will not qualify if you...
- Presence of intracranial metastases
- Target lesions previously treated with high-dose irradiation
- Lesions unsuitable for radiation therapy as determined by radiation oncologist
- Uncontrollable metastatic pleural effusion or ascites
- Other active malignancies not cured
- Significant psychiatric disorders preventing informed consent or compliance
- Serious illnesses posing risks or affecting radiation therapy
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Any other reasons judged by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months or until disease progression or discontinuation
Participants receive standard systemic therapy. Those in the SBRT arm also undergo stereotactic body radiotherapy (SBRT) to all metastatic sites, typically completed within 6 months of enrollment.
Treatment visits according to systemic therapy and radiotherapy schedules; radiotherapy typically delivered daily or every other day
Duration - Up to 5 years
Participants are monitored for disease progression, survival, treatment-related toxicity, and quality of life with periodic imaging and assessments.
Periodic imaging visits with CT, PET/CT, and/or MRI and clinical assessments over follow-up period
Trial Site Locations
Total: 9 locations
1
Union Hospital, Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
4
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
5
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
6
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
7
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Not Yet Recruiting
8
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
9
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
L
Liru He, PhD
F
Fangjian Zhou, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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