Abstract | INTRODUCTION: METHODS AND ANALYSIS: STUDY DESIGN: This trial is a single-arm cohort study sponsored by Peking University Third Hospital. STUDY TREATMENT: Preoperative stereotactic ablative radiotherapy combined with surgical treatment. PRIMARY ENDPOINTS: (1) Adverse reactions after 4-6 weeks of SABR. (2) Mayo staging of tumour thrombus. (3) The length of the tumour thrombus from the corresponding anatomical mark. (4) Invasion of the inferior vena cava wall. (5) Recurrent-free survival rate of the tumour. (6) Cancer-specific survival rate. (7) Overall survival rate. (8) Perioperative indicators including operation time, intraoperative bleeding volume and postoperative complications. SECONDARY ENDPOINTS: (1) The longest diameter of the tumour and (2) Lymph node condition. MAIN INCLUSION CRITERIA: MAIN EXCLUSION CRITERIA: Patients with previous targeted therapy, chemotherapy or other interventions, or who cannot tolerate SABR or surgery. PLANNED SAMPLE SIZE: 20 patients. ETHICS AND DISSEMINATION: The trial protocol and the informed consent of the subjects were submitted and approved by the Peking University Biomedical Ethics Committee. TRIAL REGISTRATION NUMBER: ChiCTR1800015118.
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Authors | Yunchong Liu, Zhuo Liu, Ran Peng, Ruotao Xiao, Junjie Wang, Hao Wang, Lulin Ma |
Journal | BMJ open
(BMJ Open)
Vol. 12
Issue 1
Pg. e055364
(Jan 31 2022)
ISSN: 2044-6055 [Electronic] England |
PMID | 35105644
(Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Topics |
- Carcinoma, Renal Cell
(radiotherapy, surgery)
- Cohort Studies
- Humans
- Kidney Neoplasms
(pathology, surgery)
- Nephrectomy
(methods)
- Radiosurgery
(adverse effects)
- Retrospective Studies
- Thrombectomy
(methods)
- Thrombosis
(etiology)
- Vena Cava, Inferior
(surgery)
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