Radiotherapy added to drug therapy for upper urinary tract cancer spread to few sites
Tests adding radiotherapy to drug treatment in upper urinary tract cancer.
Plain-language title generated from the registry record
Registry title: Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs
Key facts
- Where
- Beijing, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06652022, who can take part
Where in China
- Departmeng of Urology, Peking University First HospitalBeijing, ChinaTaking people
- Department of Radiotherapy Oncology, Peking University First HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT06652022
- Record updated
- 22 October 2024
- Original description
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.Read full original descriptionShow less
Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic Upper Tract Urothelial Carcinoma: a Prospective Randomised Controlled Trial
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.
Inclusion: 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: Patients who are intolerant to or have had a reduction in systemic therapy; patients with tumour progression assessed after 2 cycles of systemic therapy; 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.