Combining kidney-sparing surgery with postoperative radiotherapy for advanced ureteral cancer
Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
This study is testing if a new approach that combines kidney-sparing surgery with radiation after surgery can safely treat advanced ureteral cancer while keeping kidney function intact.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT06120387 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of kidney-sparing surgery combined with postoperative adjuvant radiotherapy in patients with high-risk locally advanced ureteral cancer. It will analyze outcomes compared to traditional radical surgery, focusing on preserving renal function while effectively treating the tumor. The study will utilize an ambispective approach, incorporating both retrospective and prospective data to assess patient outcomes and tolerability of subsequent therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with high-risk ureteral cancer who meet specific surgical criteria.
Not a fit: Patients with distant metastasis, prior pelvic or abdominal radiotherapy, or other significant malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve renal function preservation in patients while maintaining effective cancer treatment.
How similar studies have performed: While similar approaches have been explored, this specific combination of kidney-sparing surgery and postoperative radiotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing and 1 other locations
- Departmeng of Urology, Peking University First Hospital — Beijing, China (Recruiting)
- Department of Radiotherapy Oncology, Peking University First Hospital — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.