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

Inclusion Criteria8

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 Criteria9

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.

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.