Status:
UNKNOWN
Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
Lead Sponsor:
Jørgen Bjerggaard Jensen
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A randomized controlled trial aiming to investigate neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation th...
Detailed Description
Background: Bladder cancer is the 11th most common cancer in the world and one of the most costly cancers on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and i...
Eligibility Criteria
Inclusion
- Known history of urothelial non-invasive Ta-tumour low-grade or high-grade.
- ≥18 years old
- Mentally healthy individual
- The ability to understand Danish orally and in writing
Exclusion
- Known history of invasive tumour of the bladder (T1+)
- Known history of CIS of the bladder
- Previous BCG-treatment within the last 24 months
- Previous Mitomycin C-treatment (except single-shot postoperative instillation)
- Known allergy or intolerance to Mitomycin C
- Solid tumour with suspicions of invasion
- Single tumour of more than 2 cm in diameter
- Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions).
- Small bladder volume (less than 100 ml) or incontinence
- Acute cystitis
- Pregnancy or breast-feeding
- Not willing to use secure contraception with regard to men with partners and premenopausal women
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03348969
Start Date
November 1 2017
End Date
December 31 2024
Last Update
December 14 2023
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200