European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: 2023 Update.
Morgan Rouprêt, Thomas Seisen, Alison J Birtle...
https://pubmed.ncbi.nlm.nih.gov/36967359Actively Recruiting
Age: 18Years +
All Genders
ID06120387
Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
Led by Xuesong Li · Updated on 2023-11-07
90
Participants Needed
2
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with locally advanced ureteral cancer who have high-risk factors, such as multifocal tumors or advanced stages. The study aims to analyze the safety and effectiveness of surgery that preserves the kidney combined with postoperative radiotherapy, compared to the traditional radical surgery that removes the kidney. The goal is to find a treatment that maintains kidney function and improves tolerance for later drug therapies without reducing cancer control. The study includes two groups: one receiving kidney-sparing surgery followed by radiotherapy after the operation, and a comparison group undergoing radical surgery. Patients will have preoperative imaging like CT or MRI to determine disease stage. After surgery, patients may receive additional chemotherapy or radiotherapy based on their pathology and preferences. Participants will be closely monitored through follow-up visits to assess outcomes such as local recurrence-free survival at 1, 3, and 5 years, renal function around surgery and treatment, metastasis-free survival, overall survival, and recurrence in the bladder or opposite ureter. Adverse effects related to surgery and treatment will also be recorded. The total study duration spans several years with ongoing assessments to evaluate long-term safety and effectiveness.
CONDITIONS
Brief Title
Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Ureteral cancer patients with high-risk factors such as multifocal tumors, grade 3, or T2-4 stage
- Age 18 years or older
- Completed abdominopelvic CT scan within 4 weeks before enrollment showing no distant or lymph node metastasis
- No other malignant cancers in the past 5 years except non-melanoma skin cancer and ductal carcinoma in situ of the breast
- Willing to complete required examinations and follow-up and provide written informed consent
You will not qualify if you...
- Presence of distant metastasis or retroperitoneal lymph node metastasis at surgery or R2 resection patients
- History of bladder cancer
- Previous pelvic or abdominal radiotherapy
- History of inflammatory bowel disease or systemic chemotherapy
- Pregnant or breastfeeding women, or women of childbearing potential not using reliable contraception
- Active infections or bleeding disorders
- Significant cardiac diseases such as uncontrolled hypertension, unstable angina, advanced heart failure, or severe peripheral vascular disease
- Psychological, family, or social factors preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo either kidney sparing surgery or radical nephroureterectomy as part of their treatment.
1 visit (in-person)
Postoperative Radiotherapy
Duration - Duration varies based on treatment protocol
Participants in the kidney sparing surgery cohort receive postoperative radiotherapy.
Multiple radiotherapy visits as scheduled
Postoperative Follow-up
Duration - Up to 5 years
Participants are monitored for local recurrence, metastasis, renal function, and adverse effects after surgery and any postoperative radiotherapy.
Regular follow-up visits during the first 5 years
Trial Site Locations
Total: 2 locations
1
Departmeng of Urology, Peking University First Hospital
Beijing, China
Actively Recruiting
2
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Oncological Outcomes of Adjuvant Radiotherapy for Partial Ureterectomy in Distal Ureteral Urothelial Carcinoma Patients.
Hong-Zhen Li, Xiaoying Li, Xian-Shu Gao...
https://pubmed.ncbi.nlm.nih.gov/34660268A systematic review and meta-analysis of clinical trials of bladder-sparing trimodality treatment for muscle-invasive bladder cancer (MIBC).
Giorgio Arcangeli, Stefano Arcangeli, Lidia Strigari
https://pubmed.ncbi.nlm.nih.gov/25541350