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

Last updated: November 2, 2023
Sponsor: Xuesong Li
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Cancer

Treatment

Kidney sparing surgery+Postoperative radiotheray

Radical surgery

Clinical Study ID

NCT06120387
LUXUS3.0
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 ureteralresection 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.
  1. Patients did not have other malignant neoplastic diseases in the last 5 years except fornon-melanoma of the skin and ductal carcinoma in situ of the breast; Willing to participatein perfecting the necessary examinations and follow-up for the sake of the study, andwilling to provide written informed consent.

Exclusion

Exclusion Criteria:

    1. Distant metastasis or retroperitoneal lymph node metastasis (N+) had been detectedat the time of surgery; R2 resection patients; history of bladder cancer; 2) Historyof pelvic and abdominal radiotherapy; history of inflammatory bowel disease; historyof systemic chemotherapy; 3) Pregnant women or breastfeeding women; or women ofchildbearing potential who are not practicing reliable contraception; (4) The presenceof active infections in those with pre-existing or coexisting bleeding disorders 5)clinically significant cardiac disease (e.g., hypertension controlled withmedications, unstable angina, New York Heart Association (NYHA) class ≥II congestiveheart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vasculardisease); 6) Psychological, family, and social factors leading to lack of informedconsent.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Kidney sparing surgery+Postoperative radiotheray
Phase:
Study Start date:
November 10, 2023
Estimated Completion Date:
November 09, 2028

Connect with a study center

  • Departmeng of Urology, Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

  • Department of Radiotherapy Oncology, Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

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