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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Pathologically confirmed diagnosis of renal cell carcinoma of any histology - Age ≥ 18 years. - You should be able to carry out daily activities with 0 level of ability (ECOG 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

RADIATION

Stereotactic 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.

DRUG

axitinib ± 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.

Locations (9)

Union Hospital, Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Hospital of Jilin University
Changchun, Jilin, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China
Fudan University Shanghai Cancer Center
Shanghai, China