Actively Recruiting
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
Led by University Health Network, Toronto · Updated on 2025-07-20
14
Participants Needed
2
Research Sites
355 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
B
Bladder Cancer Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
- Eastern Cooperative Oncology Group (ECOG) score 0-1
- Medically appropriate candidate for radical nephroureterectomy or ureterectomy as determined by urologic oncologist
- Medically appropriate candidate for cisplatin-based chemotherapy as determined by medical oncologist
- Adequate organ function including neutrophil count ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥90 g/L, liver enzymes less than 2.5 times upper normal limit, normal electrolytes, and GFR ≥60 mL/min
- For patients randomized to adjuvant chemotherapy: pT2-4 N0-3 M0 or pT any N1-3 M0 with predominant urothelial component, ECOG score 0-2, medically appropriate for platinum-based chemotherapy, and adequate organ function with GFR ≥30 mL/min
You will not qualify if you...
- Metastatic disease
- Radiographically visible nodal disease
- Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer allowed)
- Solitary kidney
- Other cancer diagnosis or systemic chemotherapy use within 2 years before enrollment (prior bladder cancer and intravesical therapy allowed)
- Conditions excluding cisplatin chemotherapy such as deafness, grade II or higher neuropathy, or serious active infection
- Use of any other investigational drugs
- Pregnancy or breastfeeding; contraception required during treatment and for 6 months after last dose
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Actively Recruiting
2
University Health Network
Toronto, Ontario, Canada, M5G2M9
Actively Recruiting
Research Team
E
Emily Hickey
CONTACT
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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