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

January 14, 2026 updated by: ZHOU FANGJIAN, Sun Yat-sen University

Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney CancER (STROKER): A Multicenter, Randomized Controlled Phase III Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100021
        • Not yet recruiting
        • Cancer hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Yueping Liu
        • Principal Investigator:
          • Ningning Lu
        • Principal Investigator:
          • Xiongjun Ye
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Xianshu Gao
        • Principal Investigator:
          • Wei Yu
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Xuejun Ma
        • Principal Investigator:
          • Hailiang Zhang
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Union Hospital, Fujian Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Fangjian Zhou, PhD
        • Principal Investigator:
          • Liru He, PhD
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Hao Zeng
        • Contact:
        • Principal Investigator:
          • Yali Shen
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT arm
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.
Radiation: Stereotactic body radiotherapy (SBRT)
The preferred treatment plan is SBRT with a fraction dose ≥7 Gy. The prescription dose should ensure a BED of no less than 115. Radiotherapy is usually delivered daily, every other day, or other interval decided by treating radiation oncologist.
Other Names:
  • Stereotactic ablative radiotherapy
Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib
Standard systemic therapy are targeted agents or their combination with immunotherapy recommended by guidelines. This may include axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib, etc.
Other Names:
  • Standard systemic therapy
Active Comparator: Control arm
Patients receive standard systemic therapy.
Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib
Standard systemic therapy are targeted agents or their combination with immunotherapy recommended by guidelines. This may include axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib, etc.
Other Names:
  • Standard systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From enrollment to disease progression, up to 5 years
the time from randomization to the first occurrence of tumor progression or death. If no progression occurs, PFS is measured up to the date of the last follow-up.
From enrollment to disease progression, up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From enrollment to death from any cause, up to 5 years
The time from randomization to death from any cause. If no death occurs, OS is measured up to the date of the last follow-up.
From enrollment to death from any cause, up to 5 years
Cancer specific survival
Time Frame: From enrollment to death from cancer, up to 5 years
the interval from randomization to death caused by renal cancer. If no death occurs, it is measured up to the date of the last follow-up.
From enrollment to death from cancer, up to 5 years
Local control rate
Time Frame: From enrollment to in-field progression, up to 5 years
The interval from randomization to progression of each SBRT treatment lesion. If no progression occurs, it is measured up to the date of the last follow-up.
From enrollment to in-field progression, up to 5 years
Post-treatment progression free survival
Time Frame: From the initiation of systemic treatment to disease progression, up to 5 years
The time from the initiation of systemic treatment for metastasis to the first occurrence of tumor progression or death after enrollment. If no progression occurs, it is measured up to the date of the last follow-up.
From the initiation of systemic treatment to disease progression, up to 5 years
Progression-free survival 2
Time Frame: From the initiation of systemic treatment to disease progression, up to 5 years
Defined as the time from randomization to progression on the next-line treatment or death from any cause.
From the initiation of systemic treatment to disease progression, up to 5 years
Incidence of Adverse Events
Time Frame: Up to 2 years
Adverse events need to be grouped and analyzed based on treatment-related events, including all grades and grades 3-4 events. Adverse events are assessed by investigators according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Up to 2 years
Patient-Reported Adverse Events
Time Frame: Up to 2 years
Adverse events will be selected from the patient-reported outcomes (PRO) scoring system developed by the National Cancer Institute (NCI) for toxic events (specifically, the NCI PRO-CTCAE™ ITEMS Chinese version). These items will be provided to patients, who will self-assess and report any adverse events experienced during each treatment cycle.
Up to 2 years
Health-related quality of life by EQ-5D-5L
Time Frame: Up to 2 years
The overall quality of life will be evaluated using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) scale.
Up to 2 years
Health-related quality of life by FSKI
Time Frame: Up to 2 years
For assessing quality of life related to advanced kidney cancer, the Functional Assessment of Cancer Therapy - Kidney Cancer Symptom Index (FKSI), developed by the American Outcomes Research and Education Center, will be utilized, which includes both the FKSI-DRS and FKSI-19 scales.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2024

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2033

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-FXY-190
  • B2024-536-01 (Other Identifier: Sun Yat-sen University Cancer Center Clinical Research Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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