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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06120387
Other study ID # LUXUS3.0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 10, 2023
Est. completion date November 9, 2028

Study information

Verified date November 2023
Source Peking University First Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date November 9, 2028
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
China Departmeng of Urology, Peking University First Hospital Beijing
China Department of Radiotherapy Oncology, Peking University First Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Xuesong Li

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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.eururo.2023.03.013. Epub 2023 Mar 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Local recurrence free survival (LRFS) Local recurrence 1-year, 3-year and 5-year
Primary Renal Function Indicators eGFR, Crea Perioperation and peri-treatment
Secondary Metastasis free survival (MFS) Distant metastasis 1-year, 3-year and 5-year
Secondary Overall survival (OS) Overall survival 1-year, 3-year and 5-year
Secondary Intravesical and contralateral recurrence free survival(IRFS and CRFS) Intravesical and contralateral recurrence free survival 1-year, 3-year and 5-year
Secondary Adverse effects (AE) Adverse effects Perioperation and peri-treatment
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