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
  Purpose

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.


Condition
Bladder Cancer

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Recurrence Free Survival [ Time Frame: up to 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Enrollment: 551
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166230

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Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Herbert Barton Grossman, MD The University of Texas, MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT01166230     History of Changes
Other Study ID Numbers: PC B305/E10
Study First Received: July 19, 2010
Results First Received: August 5, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Austria: Ethikkommission
Netherlands: Medical Ethics Review Committee (METC)
Germany: Ethics Commission

Additional relevant MeSH terms:
Recurrence
Urinary Bladder Neoplasms
Disease Attributes
Neoplasms
Neoplasms by Site
Pathologic Processes
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014