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

Last updated: January 14, 2026
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Urothelial Tract Cancer

Carcinoma

Urothelial Cancer

Treatment

Stereotactic body radiotherapy (SBRT)

axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib

Clinical Study ID

NCT06726421
2024-FXY-190
B2024-536-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 metastaticlesions 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

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 radiationoncologist (e.g., lesions invading the gastrointestinal tract or penetrating thebronchus).

  • Uncontrollable metastatic pleural effusion or ascites.

  • Presence of other malignancies that have not been cured.

  • History of significant psychiatric disorders that impede understanding of informedconsent and compliance with the study protocol.

  • Presence of other serious illnesses that may pose significant risks or affectradiation therapy.

  • Women who are pregnant, breastfeeding, or with plans for childbearing during thestudy.

  • Any other reasons deemed by the investigator to make the subject unsuitable forparticipation in the study.

Study Design

Total Participants: 252
Treatment Group(s): 2
Primary Treatment: Stereotactic body radiotherapy (SBRT)
Phase: 3
Study Start date:
September 18, 2024
Estimated Completion Date:
September 30, 2033

Study Description

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.

III. To estimate the local control (LC) rate of SBRT. IV. To compare the post-treatment progression-free survival (post-treatment PFS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.

V. To evaluate treatment-related toxicity after adding SBRT based on patient-reported outcomes and researcher reported adverse events.

VI. To compare the quality of life between patients treated with SBRT or not using EQ-5D-5L, FKSI-DRS and FKSI-19.

OUTLINE: Patients are randomized to either Control arm or SBRT arm.

Control arm: Patients receive standard of care systemic therapy on study. SBRT arm: Patients undergo SBRT to all metastatic sites in addition to standard of care systemic therapy on study.

Patients periodically receive computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI) throughout the trial.

Connect with a study center

  • Union Hospital, Fujian Medical University

    Fuzhou 1810821, Fujian 1811017
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Active - Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764
    China

    Active - Recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing 1816670, 100021
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670, 100034
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, 200032
    China

    Active - Recruiting

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