Combining radiotherapy with systemic therapy for oligometastatic ureter cancer
Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic Upper Tract Urothelial Carcinoma: a Prospective Randomised Controlled Trial
This study tests if adding radiotherapy to standard treatment can help people with a limited number of metastatic ureter cancer spots feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT06652022 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining radiotherapy with systemic therapy in patients diagnosed with oligometastatic uroepithelial carcinoma. Participants are randomly assigned to receive either systemic therapy alone or systemic therapy plus radiotherapy. The study focuses on patients with a limited number of metastatic lesions, specifically those with metastases confined to three organs or fewer. The systemic therapy may include chemotherapy, immune checkpoint inhibitors, or a combination of treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed oligometastatic uroepithelial carcinoma and an expected survival time of at least six months.
Not a fit: Patients with brain metastases or more than three liver metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with oligometastatic ureter cancer.
How similar studies have performed: Other studies have shown promise in combining radiotherapy with systemic therapies for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with metastatic uroepithelial cancer with histologically confirmed diagnosis (pathologically confirmed primary focus or one of the metastatic foci is sufficient) (metastasis after total cystectomy, metastasis after full-length nephroureteral resection, or metastatic uroepithelial cancer of the pelvic-ureteral bladder at the first diagnosis of inoperable metastatic uroepithelial cancer). * Oligometastases were defined as ≤3 organs, and the number and size of metastatic lesions were not restricted to the extent that full-coverage radiotherapy could be met. If regional lymph node recurrence was present, all positive regional lymph nodes were collectively referred to as one lesion. Non-regional lymph node metastases are counted as metastases by lymph node subregion. * Willing and able to provide written informed consent/assent for the trial; age ≥18 years on the date of signing the informed consent form and patient age ≤80 years. * Expected survival time ≥ 6 months; * Eastern Collaborative Oncology Group (ECOG) Physical Status (PS) score of 0 to 1; * Normal major organ function, i.e., the following criteria are met: routine blood tests: a) Haemoglobin ≥ 90 g/L; b) Total bilirubin ≤ 2 x upper limit of normal (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 x ULN in the absence of liver metastases, and ALT, AST and ALP ≤ 5 x ULN in the presence of liver metastases; d) Creatinine clearance (CrCl) ≥30 mL/min; Exclusion Criteria: * Pathological type non-urothelial carcinoma; * Patients with brain metastases and \>3 liver metastases; patients with spinal bone metastases at risk of spinal cord compression; patients with pericardial, pleural or abdominopelvic fluid; * Patients who are intolerant to or have had a reduction in systemic therapy; patients with tumour progression assessed after 2 cycles of systemic therapy.
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.