RecruitingNCT06120387

Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer


Sponsor

Xuesong Li

Enrollment

90 participants

Start Date

Nov 10, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • \- 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.
  • \) 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 Criteria1

  • \) 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.

Interventions

PROCEDURERadical surgery

Radical nephroureterectomy

RADIATIONKidney sparing surgery+Postoperative radiotheray

Kidney sparing surgery+Postoperative radiotheray


Locations(2)

Departmeng of Urology, Peking University First Hospital

Beijing, China

Department of Radiotherapy Oncology, Peking University First Hospital

Beijing, China

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NCT06120387


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