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

NCT06120387 | Recruiting DMC

• 1 other identifier: LUXUS3.0
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Locally Advanced; Urothelial Carcinoma Ureter

Keywords

upper tract urothelial carcinoma; Radiotherapy; Kidney sparing surgery; Locally advanced; Ambispective cohort

Outcome Measures

Primary Outcomes (2)

• Local recurrence free survival (LRFS)

  Local recurrence

  1-year, 3-year and 5-year

• Renal Function Indicators

  eGFR, Crea

  Perioperation and peri-treatment

Secondary Outcomes (4)

• Metastasis free survival (MFS)

  1-year, 3-year and 5-year

• Overall survival (OS)

  1-year, 3-year and 5-year

• Intravesical and contralateral recurrence free survival(IRFS and CRFS)

  1-year, 3-year and 5-year

• Adverse effects (AE)

  Perioperation and peri-treatment

Study Arms (2)

Kidney sparing surgery+Postoperative radiotheray cohort

Kidney sparing surgery+Postoperative radiotheray cohort

Radiation: Kidney sparing surgery+Postoperative radiotheray

Radical surgery cohort

Preoperative CT/MRI, chest CT and other examinations are performed to determine the stage of the patient's disease. The surgical plan is the same as the current conventional treatment. After surgery, there is no restriction on the use of postoperative adjuvant chemotherapy or postoperative adjuvant radiotherapy according to the patient's pathological stage and the patient's wish.

Procedure: Radical surgery

Interventions

Radical surgery PROCEDURE

Radical nephroureterectomy

Radical surgery cohort

Kidney sparing surgery+Postoperative radiotheray RADIATION

Kidney sparing surgery+Postoperative radiotheray

Kidney sparing surgery+Postoperative radiotheray cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4)

You may qualify if:

• \- 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.
• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Xuesong Li: lead

Study Sites (2)

Departmeng of Urology, Peking University First Hospital

Beijing, China

RECRUITING

Department of Radiotherapy Oncology, Peking University First Hospital

Beijing, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 36967359 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Urology

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: November 10, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): November 9, 2028
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

CN (2)