At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed renal cell carcinoma of any histology
- ✓Age ≥18 years
- ✓Imaging confirms distant metastases with no more than 5 metastatic lesions per RECIST 1.1 and MDA standards
- ✓Prior local therapy to primary site (surgery, stereotactic radiotherapy, or ablation)
- ✕Intracranial metastases present
- ✕Target lesions previously received high-dose irradiation
- ✕Target lesions unsuitable for radiation therapy per treating radiation oncologist (e.g., invading gastrointestinal tract or penetrating bronchus)
- ✕Uncontrollable metastatic pleural effusion or ascites
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney CancER (STROKER): A Multicenter, Randomized Controlled Phase III Trial
In Brief
A Phase 3 clinical trial evaluating Stereotactic body radiotherapy (SBRT) and axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib for Renal Cell Carcinoma (Kidney Cancer) and 2 related conditions. Currently recruiting, targeting 252 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.