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Chemotherapy for Bladder Cancer (NAUTICAL Trial)

Phase 3
Recruiting
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
Age ≥18 years of age
Timeline
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
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My cancer is in the bladder or urinary tract and has not spread to distant organs.
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I am 18 years old or older.
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My blood counts and kidney function are within normal ranges.
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My doctor agrees I can undergo major surgery for kidney or ureter cancer.
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I am fully active or can carry out light work.
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My blood counts and kidney function are within normal ranges.
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I am able to get out of my bed or chair and move around.
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My doctor agrees I can undergo chemotherapy involving platinum.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My cancer is in the bladder or urinary tract and has not spread to distant parts of my body.
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I have a new diagnosis of bladder cancer that hasn't spread, confirmed by tests.
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My blood counts and kidney function are within normal ranges.
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I have been newly diagnosed with a visible bladder cancer that has not spread.
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I am able to care for myself and perform daily activities.
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My doctor agrees I can handle cisplatin-based chemotherapy.
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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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,464 Previous Clinical Trials
483,587 Total Patients Enrolled
Bladder Cancer CanadaUNKNOWN
2 Previous Clinical Trials
212 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given Gemcitabine the green light?

"Gemcitabine's safety is based on Phase 3 trial data, which suggests that the drug is efficacious and has undergone multiple rounds of safety testing."

Answered by AI

What conditions does Gemcitabine typically help?

"Commonly, advanced endometrial cancer is treated with Gemcitabine. However, this chemotherapy drug can also be effective for treating melanoma, lymphoma, non-hodgkin, and advanced sarcoma."

Answered by AI

Are you still looking for new test subjects for this clinical trial?

"Yes, as of 4/12/2022 this study is still recruiting patients, according to the listing on clinicaltrials.gov. This particular trial was first advertised on 2/8/2021."

Answered by AI
~5 spots leftby Dec 2025