Actively Recruiting
Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs
Led by Peking University First Hospital · Updated on 2024-10-22
102
Participants Needed
2
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic uroepithelial cancer confirmed by pathology at the primary site or a metastatic focus
- Oligometastases involving 3 or fewer organs, with lesion size and number allowing full-coverage radiotherapy
- All positive regional lymph nodes counted as one lesion; non-regional lymph node metastases counted by subregion
- Age between 18 and 80 years at consent
- Expected survival time of at least 6 months
- Eastern Collaborative Oncology Group (ECOG) physical status score of 0 to 1
- Normal major organ function with hemoglobin 90 g/L, total bilirubin 2 times upper limit of normal, AST/ALT/ALP 2.5 times upper limit of normal (or 5 times with liver metastases), and creatinine clearance 30 mL/min
You will not qualify if you...
- Non-urothelial carcinoma pathological types
- Brain metastases or more than 3 liver metastases
- Spinal bone metastases with risk of spinal cord compression
- Presence of pericardial, pleural, or abdominopelvic fluid
- Intolerance or prior reduction of systemic therapy
- Tumor progression after 2 cycles of systemic therapy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Departmeng of Urology, Peking University First Hospital
Beijing, China
Actively Recruiting
2
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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