OncoMatch/Clinical Trials/NCT04574960
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
Is NCT04574960 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Gemcitabine and Cisplatin for bladder cancer.
Treatment: Gemcitabine · Cisplatin · Carboplatin — Upper tract urothelial cancer (UTUC) is cancer in the lining of the kidney or ureter (the tube that drains the kidney). This type of cancer is rare and as a result, there are only a few studies that have looked at it. Standard of care for UTUC would be surgery followed by chemotherapy (adjuvant chemotherapy). However, we know from studies that have looked at cancer of the lining of the bladder, which is a similar cancer in many ways, that treating people with chemotherapy before surgery (neoadjuvant chemotherapy) can lead to longer survival compared to the standard of care. There are no studies to show this in UTUC. Neoadjuvant chemotherapy is thought to help improve survival by treating any cancer that may have spread from the original tumour but that is not visible yet on scans. This study would be the first clinical trial in Canada to evaluate the use of chemotherapy before surgery in this disease setting. Since UTUC is rare, the purpose of this study is to determine if it is possible to enrol enough patients to a trial looking at the use of chemotherapy before surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CT1-4 N0 M0
Excluded: Stage METASTATIC DISEASE, RADIOGRAPHICALLY VISIBLE NODAL DISEASE
Grade: high grade
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: intravesical therapy allowed
systemic chemotherapy use within 2 years of study enrollment (prior bladder cancer and intravesical therapy allowed)
Lab requirements
Blood counts
absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L
Kidney function
GFR ≥ 60 mL/min (neoadjuvant); GFR ≥ 30 mL/min (adjuvant)
Liver function
ALT and AST < 2.5 x upper limit of normal
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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