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The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy

Study acronym: IMGeS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion pushed from Dec 31, 2027 to Dec 31, 2028
    • Eligibility criteria expanded, about 10 words
    • Collaborators expanded, about 26 words
    v5
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2027v4
  3. Primary endpoint revisedv3
  4. Primary completion date: Jun 30, 2025 to Dec 31, 2025
    • Start date changed from estimate of Apr 30, 2024 to Nov 19, 2024
    • Interventions: Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml (Drug) to Mitomycin-C (Drug), gemcitabine (Drug)
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
Trial Details
NCT Number NCT06388720
Lead Sponsor National Cancer Center, Korea
Collaborators: Korea University Anam Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Chonnam National University Hospital
Conditions
(from sponsor)		 Bladder Cancer
Related terms Urinary Bladder Neoplasms
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov