Clinical trial NCT06120387: Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
Official title: Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Locally Advanced
Urothelial Carcinoma Ureter
Keywords: upper tract urothelial carcinoma
Radiotherapy
Kidney sparing surgery
Locally advanced
Ambispective cohort
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4)

Brief 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 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.

Primary outcomes:
measure: Local recurrence free survival (LRFS)
timeFrame: 1-year, 3-year and 5-year
measure: Renal Function Indicators
timeFrame: Perioperation and peri-treatment
Secondary outcomes:
measure: Metastasis free survival (MFS)
timeFrame: 1-year, 3-year and 5-year
measure: Overall survival (OS)
timeFrame: 1-year, 3-year and 5-year
measure: Intravesical and contralateral recurrence free survival(IRFS and CRFS)
timeFrame: 1-year, 3-year and 5-year
measure: Adverse effects (AE)
timeFrame: Perioperation and peri-treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Departmeng of Urology, Peking University First Hospital
city: Beijing
country: China
facility: Department of Radiotherapy Oncology, Peking University First Hospital
Study officials:
References:
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.
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.
citation: 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.