Combining systemic therapy with stereotactic body radiotherapy for kidney cancer with limited spread
Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney CancER (STROKER): A Multicenter, Randomized Controlled Phase III Trial
This study is testing if adding a special type of radiation therapy to standard treatment can help people with kidney cancer that has spread a little bit live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 9 sites (Fuzhou, Fujian and 8 other locations) |
| Trial ID | NCT06726421 on ClinicalTrials.gov |
What this trial studies
This phase III randomized controlled trial evaluates the effectiveness of adding stereotactic body radiation therapy (SBRT) to standard systemic therapy in patients with oligometastatic renal cell carcinoma. The study aims to compare progression-free survival and overall survival between patients receiving SBRT plus systemic therapy and those receiving systemic therapy alone. Additionally, it will assess the impact of this combined treatment on quality of life and treatment-related toxicity. Patients will undergo regular imaging assessments throughout the trial to monitor their condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed renal cell carcinoma and no more than 5 distant metastatic lesions.
Not a fit: Patients with intracranial metastases or those who have previously received high-dose irradiation to target lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly prolong survival and improve quality of life for patients with oligometastatic kidney cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian and 8 other locations
- Union Hospital, Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (Not_yet_recruiting)
- Peking University First Hospital — Beijing, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Liru He, PhD
- Email: helir@wy.sysucc.org.cn
- Phone: 0086-13631365597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.