drugset / Trial / NCT06652022

Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs

NCT06652022

Recruiting 102 enrolled Peking University First Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-01-01
Primary completion
2026-12-31
Completion
2029-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule Intravenous
Comparator Cisplatin Other / unclassified 70 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous