Combining radiotherapy with systemic therapy for oligometastatic ureter cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Departmeng of Urology, Peking University First Hospital
  Beijing, China Recruiting
• Department of Radiotherapy Oncology, Peking University First Hospital
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.