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Recruiting NCT06120387

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

— Observational Locally Advanced Urothelial Carcinoma Ureter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radical surgery, Kidney sparing surgery+Postoperative radiotheray.
Who it may be relevant to
Registry conditions: Locally Advanced, Urothelial Carcinoma Ureter. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Radical surgery
    Radical nephroureterectomy
  • Radiation Kidney sparing surgery+Postoperative radiotheray
    Kidney sparing surgery+Postoperative radiotheray

Primary outcome measures

  • Local recurrence free survival (LRFS) [Time frame: 1-year, 3-year and 5-year]
  • Renal Function Indicators [Time frame: Perioperation and peri-treatment]
Secondary outcome measures (4)
  • Metastasis free survival (MFS) [Time frame: 1-year, 3-year and 5-year]
  • Overall survival (OS) [Time frame: 1-year, 3-year and 5-year]
  • Intravesical and contralateral recurrence free survival(IRFS and CRFS) [Time frame: 1-year, 3-year and 5-year]
  • Adverse effects (AE) [Time frame: Perioperation and peri-treatment]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Departmeng of Urology, Peking University First Hospital — Beijing
  • Department of Radiotherapy Oncology, Peking University First Hospital — Beijing

Publications

  • 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 PMID 36967359
  • 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. PMID 34660268
  • 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. PMID 25541350

Identifiers

NCT: NCT06120387 · LUXUS3.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗