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Taking people in ChinaPhase 3

Radiation added to drug treatment for kidney cancer that has spread a little

Tests adding radiation to drug treatment in adults with limited spread kidney cancer.

Key facts

Who runs it
Sun Yat-sen University
Where
Beijing, Changchun, Chengdu, Fuzhou, Guangzhou, Shanghai, Wenzhou, and Wuhan, ChinaSee the 9 sites
Trial code
Registry title
Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)
Status
Recruiting
Phase
Phase 3
People taking part
252 people, planned
Started
18 Sept 2024
Expected to end
30 Sept 2033
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Stereotactic body radiotherapy (SBRT)
  • axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib
Record updated
15 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with kidney cancer (renal cell carcinoma) that has spread to no more than 5 places. It tests whether adding focused radiation to standard drug treatment helps.

Age
18 years or older
Sex
All sexes can join
Disease stage
Kidney cancer of any type, confirmed by tissue examination. Imaging shows spread to distant sites, with no more than 5 metastatic lesions.
Earlier treatment
Must have had local treatment of the main kidney tumour (surgery, stereotactic radiotherapy, or ablation). Must have had no more than 2 lines of drug (systemic) treatment.

Main reasons for not taking part

  • Metastases in the brain or skull
  • Target lesions that already had high-dose radiation
  • Target lesions that cannot be treated with radiation
  • Fluid in the chest or belly that cannot be controlled
  • Pregnant or breastfeeding women, or women planning a pregnancy during the study

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • Presence of intracranial metastases
  • Uncontrollable metastatic pleural effusion or ascites
  • 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

Where in China

  • Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaContact: Ningning LuNot yet recruiting
  • Peking University First HospitalBeijing, ChinaContact: Mingwei MaTaking people
  • The First Hospital of Jilin UniversityChangchun, ChinaContact: Ziling LiuTaking people
  • West China Hospital，Sichuan UniversityChengdu, ChinaContact: Yali ShenTaking people
  • Union Hospital, Fujian Medical UniversityFuzhou, ChinaContact: Jianhui ChenTaking people
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Liru He, PhDTaking people
  • Fudan University Shanghai Cancer CenterShanghai, ChinaContact: Xuejun MaTaking people
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Hang HuangTaking people
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Fang HuangTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • SBRT armTreatment being tested

    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.

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

  • Control armExisting treatment, for comparison

    Patients receive standard systemic therapy.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney CancER (STROKER): A Multicenter, Randomized Controlled Phase III Trial
Plain-language title
Radiation added to drug treatment for kidney cancer that has spread a littleGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 January 2026