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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)
  • axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib

Treatment groups

252 Participants
are divided into 2 treatment groups

Sponsors and collaborators