Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Oct 20, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of combining radiotherapy (a type of treatment using radiation) with systemic therapy (medication that works throughout the body) for patients with oligometastatic uroepithelial carcinoma, a form of cancer that has spread to a few other areas (defined as three or fewer organs). The goal is to see if adding radiotherapy to the standard systemic treatments—like chemotherapy or immune therapy—can improve outcomes for patients.

To participate in this study, patients should be adults aged 18 to 80 with confirmed metastatic uroepithelial cancer and an expected survival time of at least six months. They should be in fairly good health, with a specific score indicating their physical ability. Importantly, those with certain types of metastases, like brain metastases or multiple liver metastases, will not be eligible. Participants will be randomly assigned to either receive only systemic therapy or to receive both systemic therapy and radiotherapy, and they will be monitored for their response to the treatments. This trial is currently recruiting participants, aiming to find better treatment options for this challenging condition.

Gender

ALL

Eligibility 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.