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Chemotherapy for Bladder Cancer (NAUTICAL Trial)

Phase 3
Led By Girish Kulkarni, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
pT2-4 N0-3 M0 or pT any N1-3 M0 with predominant urothelial component
Eastern Cooperative Oncology Group (ECOG) score 0-1
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

NAUTICAL Trial Summary

This trial is looking at the feasibility of conducting a larger clinical trial to see if neoadjuvant chemotherapy can help improve survival for people with UTUC.

Who is the study for?
Adults with newly diagnosed high-grade urothelial cancer of the kidney or ureter, visible on scans, who are fit for surgery and chemotherapy. They must have good organ function and an ECOG score of 0-1 (indicating they are fully active or restricted in physically strenuous activity but ambulatory). Pregnant or breastfeeding individuals, those with metastatic disease, other cancers within 2 years, serious infections, or conditions excluding cisplatin use cannot participate.Check my eligibility
What is being tested?
The NAUTICAL trial is testing if giving chemotherapy before surgery can improve survival in patients with upper tract urothelial cancer. It's a first-of-its-kind study in Canada to see if this approach works like it does for similar bladder cancers. The drugs tested include Gemcitabine and Cisplatin (or Carboplatin for those not suitable for Cisplatin).See study design
What are the potential side effects?
Possible side effects from Gemcitabine and Cisplatin/Carboplatin may include nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, kidney damage (more common with Cisplatin), nerve damage causing numbness or tingling sensations.

NAUTICAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My cancer is in the bladder or urinary tract and has not spread to distant organs.
I am fully active or can carry out light work.
I am 18 years old or older.
I have a new diagnosis of bladder cancer that hasn't spread, confirmed by tests.
My blood counts and kidney function are within normal ranges.
I am able to care for myself and perform daily activities.
My blood counts and kidney function are within normal ranges.

NAUTICAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival (DFS)
Feasibility of enrolling cT1-4N0 M0 UTUC patients in a randomized trial of neoadjuvant chemotherapy versus standard of care by assessing pilot trial recruitment rates
Rate of complete pathologic response
Secondary outcome measures
Number of patients approached per site per month
Number of patients randomized per site per month
Site-specific enrolment rate

NAUTICAL Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Neoadjuvant Chemotherapy ArmExperimental Treatment2 Interventions
Gemcitabine/Cisplatin will be administered on a 3-week cycle for up to 4 cycles. This will be followed by surgical intervention (nephroureterectomy or ureterectomy).
Group II: Adjuvant Chemotherapy Arm (Standard of Care)Active Control3 Interventions
Patients will undergo surgical intervention (nephroureterectomy or ureterectomy) followed by adjuvant chemotherapy. Patients with a GFR greater or equal to 60 mL/min will receive Gemcitabine/Cisplatin while those with a GFR greater or equal to 30 mL/min but less than 60 mL/min will receive Gemcitabine/Carboplatin. Gemcitabine/Cisplatin will be administered on a 3-week cycle for up to 4 cycles. Gemcitabine/Carboplatin will be administered on a 3-week cycle for up to 4 cycles.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 3

Find a Location

Who is running the clinical trial?

Bladder Cancer CanadaUNKNOWN
2 Previous Clinical Trials
212 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,491 Previous Clinical Trials
490,010 Total Patients Enrolled
Girish Kulkarni, MDPrincipal InvestigatorUniversity Health Network - Princess Margaret Hospital

Media Library

Gemcitabine Clinical Trial Eligibility Overview. Trial Name: NCT04574960 — Phase 3
Bladder Cancer Research Study Groups: Neoadjuvant Chemotherapy Arm, Adjuvant Chemotherapy Arm (Standard of Care)
Bladder Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04574960 — Phase 3
Gemcitabine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574960 — Phase 3
~4 spots leftby Dec 2025