Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004103

Trial Description

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Title

A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to document the additional detection of papillary bladder
cancer and the reduced early recurrence due to the improved detection and resection of these
tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary
bladder cancer.

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Brief Summary in Scientific Language

In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors
(Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white
light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily
overlooked. These lesions are predictive of recurrence and progression of disease, and the
identification of these lesions is a crucial factor for the prognosis of the patient. The
present situation with 50-75% recurrence rate show the inadequacy of white light cystoscopy
for detection and resection of the lesions.

A better detection of papillary bladder cancer and early detection of CIS lesions will
provide the patient with a more complete TURB, a more optimal pharmacological treatment when
needed, may reduce the need for follow up cystoscopies and hopefully result in a better
prognosis for the patient.

The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in
the detection of histology confirmed papillary bladder cancer in patients with papillary
bladder cancer and to compare early recurrence rate after Hexvix and white light
transurethral resection (TURB) with white light TURB in patients with superficial bladder
cancer.

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Organizational Data

  •   DRKS00004103
  •   2012/10/09
  •   2005/10/04
  •   no
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Secondary IDs

  •   NCT00233402  (ClinicalTrials.gov)
  •   PC B305/02  (PhotoCure)
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Health Condition or Problem studied

  •   Bladder Cancer
  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Drug: Hexvix
  •   Procedure: Standard white light cystoscopy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   [---]*
  •   Parallel
  •   III
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Primary Outcome

- Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light; time frame: Day 0
- Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.; time frame: 9 months

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Secondary Outcome

- Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.; time frame: Day 0; The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).
The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately.
- Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.; time frame: Day 0

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Countries of Recruitment

  •   United States
  •   Austria
  •   Canada
  •   Germany
  •   Netherlands
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2005/01/31
  •   789
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

The patients should be indicated for a cystoscopic examination for suspected or verified
papillary bladder cancer and fulfill one or more of the following criteria:

- Patients with more than one initial bladder tumor confirmed on an outpatient
cystoscopy.

- Patients having recurrence within 12 months confirmed on an outpatient cystoscopy

- Patients with more than one papillary lesion at recurrence independently of the time
of the recurrence confirmed on an outpatient cystoscopy

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Exclusion Criteria

- Patients with known tumors in the prostatic urethra or distal urethra

- Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting
in marked amounts of blood in the urine, which may interfere with fluorescence
cystoscopy. Where the bleed is light, the patient should not be excluded if in the
investigator's opinion, rinsing during cystoscopy will alleviate the possible
interference with fluorescence cystoscopy).

- Patient with porphyria.

- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.

- Participation in other clinical studies with investigational drugs either
concurrently or within the last 30 days.

- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative serum or urine pregnancy test at screening and use the contraceptive pill or
intrauterine device (IUD) during the treatments and for at least one month
thereafter).

- Patients who have received BCG or chemotherapy within three months prior to the
initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of
seeding after resection.

- Conditions associated with a risk of poor protocol compliance.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Photocure
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    • The University of Texas, MD Anderson Cancer Center, Department of Urology
    • H Barton Grossman 
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    • The University of Texas, MD Anderson Cancer Center, Department of Urology
    • H Barton Grossman 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2008/08/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.