Clinical trial • Oncology
Mitomycin C for Non-muscle invasive bladder cancer
Clinical trial of Mitomycin C for Non-muscle invasive bladder cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-muscle invasive bladder cancer
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 26-11-2024
- First CTIS Authorization Date
- 28-11-2024
Trial design
Randomised, use of chemo-hyperthermia (qh) with mitomycin-c prior to transurethral bladder resection versus treatment with mitomycin-c in normothermia post-resection-controlled trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Use of chemo-hyperthermia (QH) with Mitomycin-C prior to transurethral bladder resection versus treatment with Mitomycin-C in normothermia post-resection
- Target Sample Size
- 152
Recruitment
- Planned Sample Size
- 152
- Recruitment Window Months
- 117
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 152
Spain
- Earliest CTIS Part Ii Submission Date
- 26-11-2024
- Latest Decision Or Authorization Date
- 28-11-2024
- Processing Time Days
- 2
- Number Of Sites
- 1
- Number Of Participants
- 152
Sites
- Site Name
- University Hospital Of Canary Islands
- Department Name
- Urology
- Principal Investigator Name
- Ana Plata Bello
- Principal Investigator Email
- aplabel@gobiernodecanarias.org
- Contact Person Name
- Ana Plata Bello
- Contact Person Email
- aplabel@gobiernodecanarias.org
Sponsor
Primary sponsor
- Full Name
- University Hospital Of Canary Islands
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Mitomycin-C
- Active Substance
- Mitomycin C
- Modality
- Small molecule
- Combination Treatment
- Yes
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