Renal Cell Carcinoma (Kidney Cancer)Phase 3STROKERNCT06726421
Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)
A Phase 3 study testing Stereotactic body radiotherapy (SBRT) and axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib in people with Renal Cell Carcinoma (Kidney Cancer) and Kidney Cancer Metastatic, run by Sun Yat-sen University at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer), Kidney Cancer Metastatic, Renal Cell Carcinoma Metastatic
- What is being tested?
- Stereotactic body radiotherapy (SBRT) and axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 9 sitesChina
- Study dates
- 18 Sep 2024to 30 Sep 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Ningning Lu, 0086-18611804268, ningninglu09@163.com
Yueping Liu
- Recruiting
Peking University First Hospital
Beijing, 100034
Mingwei Ma, 0086-15810160120, dr.mingweima@stu.pku.edu.cn
Xianshu Gao
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Ziling Liu, +8643188782222, ziling@jlu.edu.cn
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Yali Shen, 0086-18980605780, sylprecious@163.com
Yali Shen
- Recruiting
Union Hospital, Fujian Medical University
Fuzhou, Fujian
Jianhui Chen, +8659183357896, chenjianhui1983@qq.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Liru He, PhD, 0086-13631365597, helir@wy.sysucc.org.cn
Fangjian Zhou, PhD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xuejun Ma, 0086-18017312303, chateauma@hotmail.com
Xuejun Ma
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Hang Huang, +8657755578100, huanghang@wmu.edu.cn
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Fang Huang, +862785726114, 2022XH0002@hust.edu.cn
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Renal Cell Carcinoma (Kidney Cancer), Kidney Cancer Metastatic, Renal Cell Carcinoma Metastatic
- Being tested
- Stereotactic body radiotherapy (SBRT), axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib
- Keywords
- radiotherapy, SBRT, SABR, oligometastatic, oligometastasis
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT)Radiation
Also called Stereotactic ablative radiotherapy
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.
axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanibDrug
Also called Standard systemic therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| SBRT arm | Experimental | 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. Receives: Radiation: Stereotactic body radiotherapy (SBRT); Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib |
| Control arm | Active comparator | Patients receive standard systemic therapy. Receives: Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
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.
Measured: From enrollment to disease progression, up to 5 years
Secondary outcomes (9)
Overall survival
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.
Measured: From enrollment to death from any cause, up to 5 years
Cancer specific survival
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.
Measured: From enrollment to death from cancer, up to 5 years
Local control rate
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.
Measured: From enrollment to in-field progression, up to 5 years
Post-treatment progression free survival
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.
Measured: From the initiation of systemic treatment to disease progression, up to 5 years
Progression-free survival 2
Defined as the time from randomization to progression on the next-line treatment or death from any cause.
Measured: From the initiation of systemic treatment to disease progression, up to 5 years
Incidence of Adverse Events
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.
Measured: Up to 2 years
Patient-Reported Adverse Events
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.
Measured: Up to 2 years
Health-related quality of life by EQ-5D-5L
The overall quality of life will be evaluated using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) scale.
Measured: Up to 2 years
Health-related quality of life by FSKI
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start18 Sep 2024
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726421
- Sponsor's protocol ID
- 2024-FXY-190
- Other IDs
- B2024-536-01
- Acronym
- STROKER
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney CancER (STROKER): A Multicenter, Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT06726421
- Acronym / sponsor ID
- STROKER / 2024-FXY-190
- Conditions
- Renal Cell Carcinoma (Kidney Cancer), Kidney Cancer Metastatic, Renal Cell Carcinoma Metastatic
- Keywords
- radiotherapy, SBRT, SABR, oligometastatic, oligometastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT arm | Experimental | Radiation: Stereotactic body radiotherapy (SBRT), Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanibPatients 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. |
| Control arm | Active comparator | Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanibPatients receive standard systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)Also: Stereotactic ablative radiotherapyThe 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. | Radiation | SBRT arm |
| axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanibAlso: Standard systemic therapyStandard 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. | Drug | Control arm, SBRT arm |
Primary outcome
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.
9 secondary outcomes
Overall survival
Time frame: 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
Local control rate
Time frame: 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
Progression-free survival 2
Time frame: From the initiation of systemic treatment to disease progression, up to 5 years
Incidence of Adverse Events
Time frame: Up to 2 years
Patient-Reported Adverse Events
Time frame: Up to 2 years
Health-related quality of life by EQ-5D-5L
Time frame: Up to 2 years
Health-related quality of life by FSKI
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic body radiotherapy (SBRT) and axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib in people with Renal Cell Carcinoma (Kidney Cancer) and Kidney Cancer Metastatic, run by Sun Yat-sen University at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liru He, PhD (0086-13631365597, helir@wy.sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From enrollment to disease progression, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.