Systemic Therapy Alone or with Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)
NCT ID: NCT06726421
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
252 participants
INTERVENTIONAL
2024-09-18
2033-09-30
Brief Summary
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Detailed Description
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To compare the progression-free survival (PFS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.
SECONDARY OBJECTIVES:
I. To compare the overall survival (OS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.
II. To compare the cancer specific survival (CSS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.
III. To estimate the local control (LC) rate of SBRT. IV. To compare the post-treatment progression-free survival (post-treatment PFS) between patients receiving SBRT + standard systemic therapy versus standard systemic therapy alone.
V. To evaluate treatment-related toxicity after adding SBRT based on patient-reported outcomes and researcher reported adverse events.
VI. To compare the quality of life between patients treated with SBRT or not using EQ-5D-5L, FKSI-DRS and FKSI-19.
OUTLINE: Patients are randomized to either Control arm or SBRT arm.
Control arm: Patients receive standard of care systemic therapy on study. SBRT arm: Patients undergo SBRT to all metastatic sites in addition to standard of care systemic therapy on study.
Patients periodically receive computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI) throughout the trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
Control arm
Patients receive standard systemic therapy.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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ZHOU FANGJIAN
Principal Investigator
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Peking University First Hospital
Beijing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Liru He, PhD
Role: primary
Fangjian Zhou, PhD
Role: backup
Liru He, PhD
Role: backup
Yali Shen
Role: primary
Yali Shen
Role: backup
Hao Zeng
Role: backup
Ningning Lu
Role: primary
Yueping Liu
Role: backup
Ningning Lu
Role: backup
Xiongjun Ye
Role: backup
Mingwei Ma
Role: primary
Xianshu Gao
Role: backup
Wei Yu
Role: backup
Xuejun Ma
Role: primary
Xuejun Ma
Role: backup
Hailiang Zhang
Role: backup
Other Identifiers
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B2024-536-01
Identifier Type: OTHER
Identifier Source: secondary_id
2024-FXY-190
Identifier Type: -
Identifier Source: org_study_id