Comparing radical radiotherapy and surgery for renal pelvis cancer
Efficacy of Radical Radiotherapy Compared with Surgical Treatment in Patients with Upper Tract Urothelial Carcinoma: a Prospective Cohort Study
This study is testing whether radical radiotherapy or surgery works better for people with renal pelvis cancer to see which treatment helps them feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT06652009 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 30 patients with renal pelvis cancer to compare the effectiveness of radical radiotherapy versus radical surgery. Patients will be divided into two groups based on their treatment choice: one receiving standard nephroureterectomy and the other receiving stereotactic body radiation therapy (SBRT) or moderately segmented radical radiotherapy. The study will assess short-term efficacy using imaging and RECIST criteria one month after treatment, focusing on disease-free survival and potential remission rates. The study will also consider patient factors such as age and overall health in determining eligibility for surgery or radiotherapy.
Who should consider this trial
Good fit: Ideal candidates include patients over 70 years old or younger patients with underlying health conditions who cannot undergo surgery for renal pelvis or ureteral carcinoma.
Not a fit: Patients with distant metastases or those who are in good health and can tolerate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment options for patients with renal pelvis cancer, potentially improving patient outcomes.
How similar studies have performed: While there have been studies comparing surgical and radiotherapy approaches for various cancers, this specific comparison for renal pelvis cancer is less common, indicating a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Uroepithelial carcinoma of the renal pelvis or ureter supported by clinical symptoms, imaging, histopathology, urocytology, or fluorescence in situ hybridisation (FISH), or those who satisfy FISH positivity despite the absence of pathology or the patient's refusal to be punctured and who are judged to have a renal pelvic or ureteral carcinoma by an imaging physician and a urologist on the basis of CTU or MRU or PETCT; No distant metastases were detected on full screening; Patients who are unable to undergo surgical treatment due to poor general condition, inability to be anaesthetised or to tolerate surgery, or refusal to undergo surgery; patients who are over 70 years old; or patients who are less than 70 years old combined with underlying diseases or the presence of regional lymph node metastasis, etc. who are otherwise unable to undergo radical surgery; Expected survival ≥ 6 months; Willingness and ability to comply with trial and follow-up procedural arrangements; voluntarily agree to participate in the study and sign an informed consent form. Exclusion Criteria: * Previous abdominopelvic radiotherapy; Other serious, uncontrolled concomitant disease that may affect adherence to the protocol or interfere with interpretation of results; Other malignancies within 5 years prior to the start of study dosing, with the exception of malignancies that can be expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, cervical cancer in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery); estimated that patients' adherence to participation in this clinical study was insufficient.
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.