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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Free Survival | up to 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Progression | 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. | 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB | 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. | up to 5.5 years retrospectively |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Herbert Barton Grossman, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center, Department of Urology | Stanford | California | 94305-5820 | United States | ||
| V.A. Medical Center |
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| Label | URL |
|---|---|
| Bladder Cancer Advocacy Network (BCAN) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 PCB305/04 who were followed for recurrence. |
| FG001 | Patients With Ta/T1 Randomized to Hexvix Cystoscopy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Median Time to Recurrence | up to 4.5 years |
| Gainesville |
| Florida |
| 32608 |
| United States |
| University of Miami School of Medicine | Miami | Florida | 33136 | United States |
| South Florida Clinical Research Center, Inc. | Pembroke Pines | Florida | 33028 | United States |
| The Emory Clinic, Dept of Urology | Atlanta | Georgia | 30322 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mount Sinai Medical Center, Department of Urology | New York | New York | 10029-6574 | United States |
| URMC | Rochester | New York | 14642 | United States |
| Thomas Jefferson Medical College, Department of Neurology | Philadelphia | Pennsylvania | 19107 | United States |
| Vanderbilt University Medical Center, Department of Urologic Surgery | Nashville | Tennessee | 37232-2765 | United States |
| Baylor College of Medicine, Scott Department of Urology | Houston | Texas | 77030-2726 | United States |
| The University of Texas MD Anderson cancer center | Houston | Texas | 77030-4009 | United States |
| AKH, Klinik für Urologie der Universität Wien | Vienna | 1090 | Austria |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| CHUQ Hotel-Dieu de Quebec | Québec | G1R 2J6 | Canada |
| University Clinic of Giessen, Department of Urology | Giessen | 35392 | Germany |
| Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik | München | 81377 | Germany |
| Urologische Klinik München-Planegg | Planegg | 82152 | Germany |
| Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie | Regensburg | 93053 | Germany |
| Universitätsklinik Tuebingen, Universitätsklinik für Urologie | Tübingen | 72076 | Germany |
| Department of Urology, Academic Medical Center, University of Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Department of Urology, UMC St. Radboud | Nijmegen | 6500 HB | Netherlands |
Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB | 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. | ITT | Posted | Number | percentage of paticipants | up to 5.5 years retrospectively |
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| Other Pre-specified | Median Time to Recurrence | ITT | Posted | Median | 95% Confidence Interval | months | up to 4.5 years |
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| Primary | Recurrence Free Survival | Intention-to-treat (ITT) | Posted | Median | 95% Confidence Interval | months | up to 4.5 years |
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| Secondary | Rate of Progression | 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. | Posted | Number | percentage of patients | 4.5 years |
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There was no treatment in this clinical study, only a follow-up of previously treated patients, so assessment of safety was not applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | ||
| EG001 | Patients With Ta/T1, Randomized to White Light Cystoscopy | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Barton Grossman, MD | The University of Texas | 713-563-7456 | hbgrossman@mdanderson.org |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| Male |
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