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

Launched by SUN YAT-SEN UNIVERSITY · Dec 9, 2024

Keywords

ClinConnect Summary

The STROKER Study is a clinical trial designed to investigate whether adding a special type of radiation therapy called stereotactic body radiation therapy (SBRT) to standard treatments can help patients with a specific stage of kidney cancer live longer. This study is for adults with renal cell carcinoma (a type of kidney cancer) that has spread to other parts of the body but has only a few (no more than five) metastatic lesions. Researchers want to see if this combined treatment not only extends survival but also affects the side effects and quality of life for patients compared to those receiving standard therapy alone, which includes targeted medications and immunotherapy.

To participate in this study, individuals must be at least 18 years old, have a confirmed diagnosis of kidney cancer, and have already received treatment for their primary tumor. It's important that they have not had more than two prior systemic therapies and have good overall health without major organ issues. The study is currently looking for participants of all genders. If you or someone you know meets these criteria, you could have the opportunity to contribute to important research that may improve treatment options for kidney cancer in the future.

Gender

ALL

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.