radiotherapy combined with systemic therapy versus systemic therapy for oligometastatic utucs

Conditions: Oligometastatic Disease; Ureter Cancer; Renal Pelvic Carcinoma

Summary: this study was a prospective, open-label, phase ii randomised controlled clinical study, enrolling patients with primary oligometastatic uroepithelial carcinoma, oligometastasis was defined as ≤3 organs, and the number of metastatic lesions and size of metastases were not restricted to be able to satisfy the definition of full-coverage radiotherapy, with the exception of patients with brain metastases and more than 3 liver metastases. if regional lymph node recurrence was present, all positive regional lymph nodes were collectively referred to as one lesion. non-regional lymph node metastases were counted as the number of metastases by lymph node subregion. patients were divided into two groups according to whether they received radiotherapy or not: 1) systemic therapy group; 2) systemic therapy + radiotherapy group. systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy, or combination therapy.

this study was a prospective, open-label, phase ii randomised controlled clinical study, enrolling patients with primary oligometastatic uroepithelial carcinoma, oligometastasis was defined as ≤3 organs, and the number of metastatic lesions and size of metastases were not restricted to be able to satisfy the definition of full-coverage radiotherapy, with the exception of patients with brain metastases and more than 3 liver metastases. if regional lymph node recurrence was present, all positive regional lymph nodes were collectively referred to as one lesion. non-regional lymph node metastases were counted as the number of metastases by lymph node subregion. patients were divided into two groups according to whether they received radiotherapy or not: 1) systemic therapy group; 2) systemic therapy + radiotherapy group. systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy, or combination therapy.

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.

Keywords: oligometastatic disease upper tract urothelial carcinoma systematic radiotherapy randomized control trial