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Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

Study acronym: NAUTICAL
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from University Health Network, Toronto

Record History

  1. Primary completion pushed from Dec 2026 to Dec 2027 Completion pushed from Dec 2027 to Dec 2028 · Eligibility criteria expanded, about 18 words Show 2 more changesShow less
    • Completion pushed from Dec 2027 to Dec 2028
    • Eligibility criteria expanded, about 18 words
  2. Primary completion date: Dec 2025 to Dec 2026 Completion date: Dec 2025 to Dec 2027v7 Show 1 more changeShow less
    • Completion date: Dec 2025 to Dec 2027
  3. Primary completion date: Dec 2023 to Dec 2025 Completion date: Feb 2025 to Dec 2025v6 Show 1 more changeShow less
    • Completion date: Feb 2025 to Dec 2025
  4. Study sites: 1 to 2v5
  5. Primary completion date: Dec 2022 to Dec 2023 Eligibility criteria expanded, about 4 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Feb 2022 to Dec 2022 Site contact updatedv3 Show 1 more changeShow less
    • Site contact updated
  2. Start date changed from estimate of Oct 2020 to Feb 8, 2021 Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04574960
Lead Sponsor University Health Network, Toronto
Collaborators: Bladder Cancer Canada
Conditions Bladder Cancer, Bladder Urothelial Carcinoma
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov