NCT04574960

Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

Neoadjuvant Chemotherapy in Upper Tract Urothelial Cancer: A Multicentre, Feasibility Pilot Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Bladder Cancer
• Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2, IV infusion on days 1 and 8 of each 3-week cycle
DRUG	Cisplatin	Cisplatin 70 mg/m\^2, IV infusion on day 1 of each 3-week cycle
DRUG	Carboplatin	Carboplatin AUC 5-6 calculated using the Calvert formula on day 1 of each cycle

Timeline

• Start date: 2021-02-08
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2020-10-05
• Last updated: 2025-07-20

Locations

2 sites across 1 country: Canada