Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Phase 4

Withdrawn

• Conditions: Bladder Cancer
• Interventions: Drug: hexaminolevulinate

• Registration Number: NCT00785694
• Lead Sponsor: GE Healthcare

Brief Summary

This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Study Start: 2008-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• The subject is not of childbearing potential and signed informed consent.
• Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.

Exclusion Criteria

• The subject was previously included in this study.
• The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
• The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.
• The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
• The subject has gross haematuria.
• The subject has a history of porphyria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	hexaminolevulinate	One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.

Primary Outcome Measures

Name	Time	Method
Rate of bladder cancer recurrence	12 Months

Trial Locations

Locations (1)

GE Healthcare Medical Diagnostics; 🇫🇷 Velizy Cedex, Morane Saulnier, France