NCT06726421 Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)
| NCT ID | NCT06726421 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Renal Cell Carcinoma (Kidney Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 252 participants in total. It began in 2024-09-18 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06726421 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma (Kidney Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06726421 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 252 participants.
Is NCT06726421 currently recruiting?
Yes, NCT06726421 is actively recruiting participants. Contact the research team at helir@wy.sysucc.org.cn for enrollment information.
Where is the NCT06726421 trial being conducted?
This trial is being conducted at Fuzhou, China, Guangzhou, China, Wuhan, China, Changchun, China and 5 additional locations.
Who is sponsoring the NCT06726421 clinical trial?
NCT06726421 is sponsored by Sun Yat-sen University. The trial plans to enroll 252 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.