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Trial Title:
Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
NCT ID:
NCT06120387
Condition:
Locally Advanced
Urothelial Carcinoma Ureter
Conditions: Official terms:
Carcinoma, Transitional Cell
Ureteral Neoplasms
Conditions: Keywords:
upper tract urothelial carcinoma
Radiotherapy
Kidney sparing surgery
Locally advanced
Ambispective cohort
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Procedure
Intervention name:
Radical surgery
Description:
Radical nephroureterectomy
Arm group label:
Radical surgery cohort
Intervention type:
Radiation
Intervention name:
Kidney sparing surgery+Postoperative radiotheray
Description:
Kidney sparing surgery+Postoperative radiotheray
Arm group label:
Kidney sparing surgery+Postoperative radiotheray cohort
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.
Criteria for eligibility:
Study pop:
Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3;
T2-4)
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Departmeng of Urology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuesong Li, M.D.
Phone:
+86-15801399116
Email:
pineneedle@sina.com
Contact backup:
Last name:
Chunru Xu, M.D.
Phone:
+86-17812172086
Email:
xcrbdyy@126.com
Facility:
Name:
Department of Radiotherapy Oncology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianshu Gao, M.D.
Email:
doctorgaoxs@126.com
Contact backup:
Last name:
Xiaoying Li, M.D.
Phone:
+86-13716109164
Email:
13716109164@139.com
Start date:
November 10, 2023
Completion date:
November 9, 2028
Lead sponsor:
Agency:
Xuesong Li
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120387
