Bladder Cancer Clinical Trial
Official 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
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.
Status | Completed |
Enrollment | 789 |
Est. completion date | August 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Austria | AKH, Klinik für Urologie der Universität Wien | Wien | |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | CHUQ Hotel-Dieu de Quebec | Quebec | |
Germany | University Clinic of Giessen, Department of Urology | Giessen | |
Germany | Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik | München | |
Germany | Urologische Klinik München-Planegg | Planegg | |
Germany | Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie | Regensburg | |
Germany | Universitätsklinik Tuebingen, Universitätsklinik für Urologie | Tuebingen | |
Netherlands | Department of Urology, Academic Medical Center, University of Amsterdam | Amsterdam | |
Netherlands | Department of Urology, UMC St. Radboud | Nijmegen | |
United States | St. Joseph Mercy Hospital- Ann Arbor | Ann Arbor | Michigan |
United States | The Emory Clinic, Dept of Urology | Atlanta | Georgia |
United States | Urological Institute at Beachwood Cleveland Clinic | Beachwood | Ohio |
United States | Boston University School of Medicine | Boston | Massachusetts |
United States | V.A. Medical Center | Gainesville | Florida |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Baylor College of Medicine, Scott Department of Urology | Houston | Texas |
United States | University of Miami School of Medicine | Miami | Florida |
United States | Vanderbilt University Medical Center, Department of Urologic Surgery | Nashville | Tennessee |
United States | Mount Sinai Medical Center, Department of Urology | New York | New York |
United States | South Florida Clinical Research Center, Inc. | Pembroke Pines | Florida |
United States | Thomas Jefferson Medical College, Department of Neurology | Philadelphia | Pennsylvania |
United States | URMC | Rochester | New York |
United States | Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester | Rochester | Minnesota |
United States | Stanford Cancer Center, Department of Urology | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Photocure |
United States, Austria, Canada, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light | Day 0 | No | |
Primary | 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. | 9 months | No | |
Secondary | Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy. | 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. |
Day 0 | No |
Secondary | Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light. | Day 0 | No |
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