RecruitingPhase 3NCT06726421

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

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

Sponsor

Sun Yat-sen University

Enrollment

252 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma Metastatic Renal Cell Carcinoma (Kidney Cancer)Kidney Cancer Metastatic

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares standard systemic drug therapy alone versus systemic therapy plus stereotactic body radiotherapy (SBRT — a focused, high-dose radiation treatment) for patients with kidney cancer that has spread to a limited number of sites (oligometastatic disease). **You may be eligible if...** - Have confirmed renal cell carcinoma (kidney cancer), any subtype - Age 18 or older - Have no more than 5 detectable metastatic lesions (limited spread) - In adequate overall health (ECOG 0–2) - Being considered for systemic therapy **You may NOT be eligible if...** - Have more than 5 metastatic lesions - Have cancer spread to the brain - Are unable to tolerate radiation therapy for other medical reasons - Have had prior SBRT to the same sites Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic 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.

DRUGaxitinib ± 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.