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| ID | Type | Description | Link |
|---|---|---|---|
| B2024-536-01 | Other Identifier | Sun Yat-sen University Cancer Center Clinical Research Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT arm | Experimental | 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. |
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| Control arm | Active Comparator | Patients receive standard systemic therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | the time from randomization to the first occurrence of tumor progression or death. If no progression occurs, PFS is measured up to the date of the last follow-up. | From enrollment to disease progression, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from randomization to death from any cause. If no death occurs, OS is measured up to the date of the last follow-up. | From enrollment to death from any cause, up to 5 years |
| Cancer specific survival |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liru He, PhD | Contact | 0086-13631365597 | helir@wy.sysucc.org.cn | |
| Fangjian Zhou, PhD | Contact | 0086-13922735659 | zhoufj@wy.sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
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| 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. |
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the interval from randomization to death caused by renal cancer. If no death occurs, it is measured up to the date of the last follow-up.
| From enrollment to death from cancer, up to 5 years |
| Local control rate | The interval from randomization to progression of each SBRT treatment lesion. If no progression occurs, it is measured up to the date of the last follow-up. | From enrollment to in-field progression, up to 5 years |
| Post-treatment progression free survival | The time from the initiation of systemic treatment for metastasis to the first occurrence of tumor progression or death after enrollment. If no progression occurs, it is measured up to the date of the last follow-up. | From the initiation of systemic treatment to disease progression, up to 5 years |
| Progression-free survival 2 | Defined as the time from randomization to progression on the next-line treatment or death from any cause. | From the initiation of systemic treatment to disease progression, up to 5 years |
| Incidence of Adverse Events | Adverse events need to be grouped and analyzed based on treatment-related events, including all grades and grades 3-4 events. Adverse events are assessed by investigators according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Up to 2 years |
| Patient-Reported Adverse Events | Adverse events will be selected from the patient-reported outcomes (PRO) scoring system developed by the National Cancer Institute (NCI) for toxic events (specifically, the NCI PRO-CTCAE™ ITEMS Chinese version). These items will be provided to patients, who will self-assess and report any adverse events experienced during each treatment cycle. | Up to 2 years |
| Health-related quality of life by EQ-5D-5L | The overall quality of life will be evaluated using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) scale. | Up to 2 years |
| Health-related quality of life by FSKI | For assessing quality of life related to advanced kidney cancer, the Functional Assessment of Cancer Therapy - Kidney Cancer Symptom Index (FKSI), developed by the American Outcomes Research and Education Center, will be utilized, which includes both the FKSI-DRS and FKSI-19 scales. | Up to 2 years |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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| Cancer Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | 100021 | China |
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| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D000077210 | Sunitinib |
| C516667 | pazopanib |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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