Combining systemic therapy with stereotactic body radiotherapy for kidney cancer with limited spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III randomized controlled trial evaluates the effectiveness of adding stereotactic body radiation therapy (SBRT) to standard systemic therapy in patients with oligometastatic renal cell carcinoma. The study aims to compare progression-free survival and overall survival between patients receiving SBRT plus systemic therapy and those receiving systemic therapy alone. Additionally, it will assess the impact of this combined treatment on quality of life and treatment-related toxicity. Patients will undergo regular imaging assessments throughout the trial to monitor their condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital, Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting
• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Liru He, PhD
• Email: helir@wy.sysucc.org.cn
• Phone: 0086-13631365597

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.