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

Sponsor
Sun Yat-sen University
Study ID
NCT06726421
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 18, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2033

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SBRT arm
    Patients undergo SBRT to all metastatic sites in addition to standard systemic therapy. Patients should complete radiotherapy for all lesions within 6 months of enrollment, preferably within the first 3 months.
  • Active Comparator: Control arm
    Patients receive standard systemic therapy.

Primary Outcome Measure

Progression free survival [ Time Frame: From enrollment to disease progression, up to 5 years ]

Central Contacts

Related Studies