Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT04574960
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed radiographically visible (CT or MRI) cT1-4 N0 M0 with positive selective urinary cytology, positive bladder urinary cytology, or endoscopic biopsy for high grade urothelial cell carcinoma
* Age ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) score 0-1
* Medically appropriate candidate for radical nephroureterectomy or ureterectomy as per participating site attending urologic oncologist
* Medically appropriate candidate for cisplatin-based chemotherapy as per participating site attending medical oncologist
* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST \< 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 60 mL/min
Patients who are randomized to the adjuvant chemotherapy will be reassessed for suitability to receive adjuvant chemotherapy after definitive surgery (nephroureterectomy or ureterectomy) based on the following criteria:
* pT2-4 N0-3 M0 or pT any N1-3 M0 with predominant urothelial component
* ECOG score 0-2
* Medically appropriate candidate for platin-based chemotherapy as per participating site attending medical oncologist
* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST \< 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 30 mL/min
Exclusion Criteria:
* Metastatic disease
* Radiographically visible nodal disease
* Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)
* Solitary kidney
* Other cancer diagnosis or systemic chemotherapy use within 2 years of study enrollment (prior bladder cancer and intravesical therapy allowed)
* Concomitant diseases that are a formal exclusion to cisplatin chemotherapy (deafness, ≥ grade II neuropathy, serious active infection)
* Concomitant use of any other investigational drugs
* Pregnancy or breast feeding (you must remain on contraception, not father a child or donate sperm while receiving gemcitabine/cisplatin and for 6 months following the last dose)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04574960
Study Brief:
Protocol Section:
NCT04574960