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Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)

RecruitingPhase 3Ages 18 Years - anyAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Pathologically confirmed diagnosis of renal cell carcinoma of any histology * Age ≥ 18 years. * ECOG performance status of 0-2. * 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 Exclusion Criteria: * 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.
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What it tests

  • Stereotactic body radiotherapy (SBRT)
  • axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib
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Where

9 sites
Union Hospital, Fujian Medical University
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The First Hospital of Jilin University
Changchun, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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