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In this study, we propose to conduct an ambispective study to analyze the safety of preserved renal unit surgery combined with postoperative adjuvant radiotherapy in patients with limited stage ureteral cancer with high risk factors, and the efficacy analysis compared with traditional radical surgery. It is hoped that a treatment method that preserves patients' renal function to improve the tolerance of subsequent drug therapy without decreasing the effect of tumor treatment can be achieved in patients with high-risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney sparing surgery+Postoperative radiotheray cohort | Kidney sparing surgery+Postoperative radiotheray cohort |
| |
| Radical surgery cohort | Preoperative CT/MRI, chest CT and other examinations are performed to determine the stage of the patient's disease. The surgical plan is the same as the current conventional treatment. After surgery, there is no restriction on the use of postoperative adjuvant chemotherapy or postoperative adjuvant radiotherapy according to the patient's pathological stage and the patient's wish. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical surgery | Procedure | Radical nephroureterectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence free survival (LRFS) | Local recurrence | 1-year, 3-year and 5-year |
| Renal Function Indicators | eGFR, Crea | Perioperation and peri-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Metastasis free survival (MFS) | Distant metastasis | 1-year, 3-year and 5-year |
| Overall survival (OS) | Overall survival | 1-year, 3-year and 5-year |
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Inclusion Criteria:
- 1) Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4); surgery may be performed with patients undergoing partial terminal ureteral resection or radical nephroureterectomy 2)Age ≥18 years; 3)Completion of abdominopelvic CT 4 weeks before enrollment to exclude distant metastasis and regional lymph node metastasis.
4) Patients did not have other malignant neoplastic diseases in the last 5 years except for non-melanoma of the skin and ductal carcinoma in situ of the breast; Willing to participate in perfecting the necessary examinations and follow-up for the sake of the study, and willing to provide written informed consent.
Exclusion Criteria:
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Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departmeng of Urology, Peking University First Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36967359 | Background | Roupret M, Seisen T, Birtle AJ, Capoun O, Comperat EM, Dominguez-Escrig JL, Gurses Andersson I, Liedberg F, Mariappan P, Hugh Mostafid A, Pradere B, van Rhijn BWG, Shariat SF, Rai BP, Soria F, Soukup V, Wood RG, Xylinas EN, Masson-Lecomte A, Gontero P. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: 2023 Update. Eur Urol. 2023 Jul;84(1):49-64. doi: 10.1016/j.eururo.2023.03.013. Epub 2023 Mar 24. | |
| 34660268 |
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| Kidney sparing surgery+Postoperative radiotheray |
| Radiation |
Kidney sparing surgery+Postoperative radiotheray |
|
| Intravesical and contralateral recurrence free survival(IRFS and CRFS) | Intravesical and contralateral recurrence free survival | 1-year, 3-year and 5-year |
| Adverse effects (AE) | Adverse effects | Perioperation and peri-treatment |
| Department of Radiotherapy Oncology, Peking University First Hospital | Recruiting | Beijing | China |
|
| Background |
| Li HZ, Li X, Gao XS, Qi X, Ma MW, Qin S. Oncological Outcomes of Adjuvant Radiotherapy for Partial Ureterectomy in Distal Ureteral Urothelial Carcinoma Patients. Front Oncol. 2021 Sep 30;11:699210. doi: 10.3389/fonc.2021.699210. eCollection 2021. |
| 25541350 | Background | Arcangeli G, Arcangeli S, Strigari L. A systematic review and meta-analysis of clinical trials of bladder-sparing trimodality treatment for muscle-invasive bladder cancer (MIBC). Crit Rev Oncol Hematol. 2015 Apr;94(1):105-15. doi: 10.1016/j.critrevonc.2014.11.007. Epub 2014 Dec 4. |