Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
- Conditions
- Locally AdvancedUrothelial Carcinoma Ureter
- Interventions
- Procedure: Radical surgeryRadiation: Kidney sparing surgery+Postoperative radiotheray
- Registration Number
- NCT06120387
- Lead Sponsor
- Xuesong Li
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
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- 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.
- 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.
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- Distant metastasis or retroperitoneal lymph node metastasis (N+) had been detected at the time of surgery; R2 resection patients; history of bladder cancer; 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3) Pregnant women or breastfeeding women; or women of childbearing potential who are not practicing reliable contraception; (4) The presence of active infections in those with pre-existing or coexisting bleeding disorders 5) clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease); 6) Psychological, family, and social factors leading to lack of informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radical surgery cohort Radical surgery 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. Kidney sparing surgery+Postoperative radiotheray cohort Kidney sparing surgery+Postoperative radiotheray Kidney sparing surgery+Postoperative radiotheray cohort
- Primary Outcome Measures
Name Time Method Renal Function Indicators Perioperation and peri-treatment eGFR, Crea
Local recurrence free survival (LRFS) 1-year, 3-year and 5-year Local recurrence
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 1-year, 3-year and 5-year Overall survival
Adverse effects (AE) Perioperation and peri-treatment Adverse effects
Intravesical and contralateral recurrence free survival(IRFS and CRFS) 1-year, 3-year and 5-year Intravesical and contralateral recurrence free survival
Metastasis free survival (MFS) 1-year, 3-year and 5-year Distant metastasis
Trial Locations
- Locations (2)
Departmeng of Urology, Peking University First Hospital
🇨🇳Beijing, China
Department of Radiotherapy Oncology, Peking University First Hospital
🇨🇳Beijing, China