N/A
N=551
Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01166230 ↗Enrolled (actual)
551
Serious AEs
—
Results posted
Nov 2013
Primary outcome: Primary: Recurrence Free Survival — 9.6; 16.4 months — p=0.056
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Photocure
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence Free Survival |
9.6; 16.4 | 0.056 |
| SECONDARY Rate of Progression |
6.1; 3.1 | — |
Summary
The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
Eligibility Criteria
Inclusion Criteria
- Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are eligible to be included in this study.
Exclusion Criteria
- Patient died during clinical study PC B305/04
Data sourced from ClinicalTrials.gov (NCT01166230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.