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

Официальное название

Systemic Therapy Combined With Radiotherapy Versus Systemic Therapy Alone for Oligometastatic Kidney CancER (STROKER): A Multicenter, Randomized Controlled Phase III Trial

Обзор

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.

Подробное описание

PRIMARY OBJECTIVES:

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.

Вмешательства

• Лучевая терапия 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.
• Препарат 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.

Первичные конечные точки

• Progression free survival [Срок оценки: From enrollment to disease progression, up to 5 years]

Вторичные конечные точки (9)

• Overall survival [Срок оценки: From enrollment to death from any cause, up to 5 years]
• Cancer specific survival [Срок оценки: From enrollment to death from cancer, up to 5 years]
• Local control rate [Срок оценки: From enrollment to in-field progression, up to 5 years]
• Post-treatment progression free survival [Срок оценки: From the initiation of systemic treatment to disease progression, up to 5 years]
• Progression-free survival 2 [Срок оценки: From the initiation of systemic treatment to disease progression, up to 5 years]
• Incidence of Adverse Events [Срок оценки: Up to 2 years]
• Patient-Reported Adverse Events [Срок оценки: Up to 2 years]
• Health-related quality of life by EQ-5D-5L [Срок оценки: Up to 2 years]
• Health-related quality of life by FSKI [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• Union Hospital, Fujian Medical University — Фучжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• The First Hospital of Jilin University — Changchun
• West China Hospital, Sichuan University — Чэнду
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин
• Peking University First Hospital — Пекин
• … и ещё 1 центр

Идентификаторы

NCT: NCT06726421 · 2024-FXY-190 · B2024-536-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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