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

Locally Advanced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120387
• Other study ID #: LUXUS3.0
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Locally Advanced
• Ureteral Neoplasms
• Urothelial Carcinoma Ureter

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