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

Sponsor

Xuesong Li (Other)

Overall Status

Recruiting

CT.gov ID

NCT06120387

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Urothelial Carcinoma Ureter	Procedure: Radical surgery Radiation: Kidney sparing surgery+Postoperative radiotheray

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 10, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Nov 9, 2028

Arms and Interventions

Arm	Intervention/Treatment
Kidney sparing surgery+Postoperative radiotheray cohort Kidney sparing surgery+Postoperative radiotheray cohort	Radiation: Kidney sparing surgery+Postoperative radiotheray 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 Radical nephroureterectomy

Arm

Intervention/Treatment

Kidney sparing surgery+Postoperative radiotheray cohort

Radiation: Kidney sparing surgery+Postoperative radiotheray

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

Radical nephroureterectomy

Outcome Measures

Primary Outcome Measures

Local recurrence free survival (LRFS) [1-year, 3-year and 5-year]
Local recurrence
Renal Function Indicators [Perioperation and peri-treatment]
eGFR, Crea

Secondary Outcome Measures

Metastasis free survival (MFS) [1-year, 3-year and 5-year]
Distant metastasis
Overall survival (OS) [1-year, 3-year and 5-year]
Overall survival
Intravesical and contralateral recurrence free survival(IRFS and CRFS) [1-year, 3-year and 5-year]
Intravesical and contralateral recurrence free survival
Adverse effects (AE) [Perioperation and peri-treatment]
Adverse effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departmeng of Urology, Peking University First Hospital	Beijing		China
2	Department of Radiotherapy Oncology, Peking University First Hospital	Beijing		China