Locally Advanced, Urothelial Carcinoma Ureter
Conditions
Keywords
upper tract urothelial carcinoma, Radiotherapy, Kidney sparing surgery, Locally advanced, Ambispective cohort
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.
Interventions
PROCEDURERadical surgery
Radical nephroureterectomy
RADIATIONKidney sparing surgery+Postoperative radiotheray
Kidney sparing surgery+Postoperative radiotheray
Sponsors
Xuesong Li
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence free survival (LRFS) | 1-year, 3-year and 5-year | Local recurrence |
| Renal Function Indicators | Perioperation and peri-treatment | eGFR, Crea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed