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Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs

RecruitingNAAges 18 Years - 80 YearsAllPeking University First Hospital
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In plain words

What the trial is, and whether it could suit you

This study was a prospective, open-label, phase II randomised controlled clinical study, enrolling patients with primary oligometastatic uroepithelial carcinoma, oligometastasis was defined as โ‰ค3 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 check

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค3 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 โ‰ฅ18 years on the date of signing the informed consent form and patient age โ‰ค80 years. * Expected survival time โ‰ฅ 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 โ‰ฅ 90 g/L; b) Total bilirubin โ‰ค 2 x upper limit of normal (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) โ‰ค 2.5 x ULN in the absence of liver metastases, and ALT, AST and ALP โ‰ค 5 x ULN in the presence of liver metastases; d) Creatinine clearance (CrCl) โ‰ฅ30 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.
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What it tests

  • Systematic therapy combined with radiotherapy
  • Systematic drug treatment
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Where

2 sites
Departmeng of Urology, Peking University First Hospital
Beijing, China
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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