Actively Recruiting
Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)
Led by Sun Yat-sen University · Updated on 2026-01-15
252
Participants Needed
9
Research Sites
471 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 metastatic lesions according to RECIST 1.1 criteria and MDA standards
- Prior local therapy to the primary tumor site such as surgery, stereotactic radiotherapy, or ablation
- Received no more than 2 lines of systemic therapy
- Adequate major organ function with hemoglobin 80 g/L, absolute neutrophil count 1.5 10/L, platelets 75 10/L, serum total bilirubin 1.5 times upper limit of normal, ALT and AST 3 times upper limit of normal, and prothrombin time and activated partial thromboplastin time 1.5 times upper limit of normal
You will not qualify if you...
- Presence of intracranial metastases
- Target lesions previously treated with high-dose irradiation
- Target lesions unsuitable for radiation therapy as judged by radiation oncologist (e.g., invading gastrointestinal tract or bronchus)
- Uncontrollable metastatic pleural effusion or ascites
- Presence of other active malignancies not cured
- History of significant psychiatric disorders preventing informed consent or protocol compliance
- Presence of other serious illnesses posing risks or affecting radiation therapy
- Women who are pregnant, breastfeeding, or planning to have children during the study
- Any other condition deemed by the investigator to make participation unsuitable
AI-Screening
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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
CONTACT
F
Fangjian Zhou, PhD
CONTACT
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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