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Chemotherapy for Bladder Cancer (NAUTICAL Trial)

Toronto, Canada

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

Eastern Cooperative Oncology Group (ECOG) score 0-1

Must not have

Solitary kidney

Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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).

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.

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 fully active or can carry out light work.

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I am 18 years old or older.

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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 am able to care for myself and perform daily activities.

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My blood counts and kidney function are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have only one kidney.

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My bladder cancer has not spread into the bladder muscles.

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My cancer has spread to my lymph nodes and can be seen on scans.

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I do not have hearing loss, severe nerve damage, or serious infections.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free survival (DFS)

Rate of complete pathologic response

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1320

Cisplatin

2013

Completed Phase 3

~3040