Status:
RECRUITING
Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
Lead Sponsor:
Xuesong Li
Conditions:
Locally Advanced
Urothelial Carcinoma Ureter
Eligibility:
All Genders
18+ years
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 ureter...
Eligibility Criteria
Inclusion
- \- 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
- 1\) 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.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 9 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06120387
Start Date
November 10 2023
End Date
November 9 2028
Last Update
November 7 2023
Active Locations (2)
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1
Departmeng of Urology, Peking University First Hospital
Beijing, China
2
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China