Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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B

One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.

Group Type EXPERIMENTAL

hexaminolevulinate

Intervention Type DRUG

Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.

A

Multiple instillations of mitomycin C after transurethral resection in white light alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hexaminolevulinate

Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.

Intervention Type DRUG

Other Intervention Names

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Hexvix

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No