Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT01166230
First received: July 19, 2010
Last updated: November 14, 2013
Last verified: November 2013

July 19, 2010
November 14, 2013
June 2010
December 2010   (final data collection date for primary outcome measure)
Recurrence Free Survival [ Time Frame: up to 4.5 years ] [ Designated as safety issue: No ]
Longer-term recurrence-free rates after Hexvix (Cysview) and non-Hexvix (Cysview) cystoscopy/TURB [ Time Frame: up to 5.5 years retrospectively ] [ Designated as safety issue: No ]
To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.
Complete list of historical versions of study NCT01166230 on ClinicalTrials.gov Archive Site
Rate of Progression [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
Only patients with Ta/T1 were included in the follow-up study. "Progression" is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence.
Not Provided
  • Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB [ Time Frame: up to 5.5 years retrospectively ] [ Designated as safety issue: No ]
    To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.
  • Median Time to Recurrence [ Time Frame: up to 4.5 years ] [ Designated as safety issue: No ]
Not Provided
 
Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB
An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB305/04, to Assess Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Transurethral Resection of the Bladder (TURB) or White Light Cystoscopy/TURB

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.

A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone.

The present 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 also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

No safety data was collected.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients with non-invasive papillary bladder cancer, enrolled in the previously completed pivotal phase III study PC B305/04, who were followed for recurrence will be included in this study.

Bladder Cancer
Not Provided
  • Patients with Ta/T1, randomized to white light cystoscopy
    Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
  • Patients with Ta/T1 randomized to Hexvix cystoscopy
    Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
551
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Germany,   Netherlands
 
NCT01166230
PC B305/E10
No
PhotoCure
PhotoCure
Not Provided
Principal Investigator: Herbert Barton Grossman, MD The University of Texas, MD Anderson Cancer Center
PhotoCure
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP