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Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

NCT04574960 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-07-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bladder Cancer Canada

    collaborator UNKNOWN

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Girish Kulkarni, MD · University Health Network - Princess Margaret Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04574960 on ClinicalTrials.gov