Spots Global Cancer Trial Database for Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
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Trial Identification
Brief Title: Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-612)
Study ID: NCT00598806
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
Detailed Description: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder. A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3). * If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). * If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). All patients were to be followed for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Advanced Urology Medical Center Clinical Trials, Anaheim, California, United States
Hal J. Bashein, D.O., West Palm Beach, Florida, United States
Urology Enterprises, Marietta, Georgia, United States
North Fulton Urology, Roswell, Georgia, United States
Hines VA Hospital, Hines, Illinois, United States
The Urology Center, Slidell, Louisiana, United States
Chesapeake Urology Research Associates, Baltimore, Maryland, United States
Chesapeake Urology Research Associates, Towson, Maryland, United States
William Beaumont Hospital, Royal Oak, Michigan, United States
PharmaTrials, Inc. - Male & Female Urology, Hillsborough, New Jersey, United States
PharmaTrials, Inc., Hillsborough, New Jersey, United States
Medical & Clinical Research Associates, LLC, Bay Shore, New York, United States
Urology Associates, PC, Manhasset, New York, United States
North Shore - LIJ Health System - The Arthur Smith Institute for Urology, New Hyde Park, New York, United States
Alliance Urology Specialists, Greensboro, North Carolina, United States
Piedmont Medical Research, Winston-Salem, North Carolina, United States
Center for Urologic Care, Bryn Mawr, Pennsylvania, United States
Medical University of South Carolina, Dept. of Urology, Charleston, South Carolina, United States
Urology Associates of South Texas, McAllen, Texas, United States
Salt Lake Research, Salt Lake City, Utah, United States
Adult and Pediatric Urologists, Alexandria, Virginia, United States
Prostate Cancer Institute, Calgary, Alberta, Canada
Lintor Medical, Inc., North Vancouver, British Columbia, Canada
Andreou Research, Surrey, British Columbia, Canada
Can-Med Clinical Research, Inc, Victoria, British Columbia, Canada
G. Steinhoff Clinical Research, Victoria, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
The Male/Female Health and Research Center - Royal Court Medical Centre, Barrie, Ontario, Canada
Brantford Urology Research, Brantford, Ontario, Canada
G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario, Canada
Urology Resource Centre, Burlington, Ontario, Canada
Kingston General Hospital / Queen's University, Kingston, Ontario, Canada
Urology Associates, Urologic Medical Research, Kitchener, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Mor Urology, Inc., Newmarket, Ontario, Canada
Dr. Bernard Goldfarb, North Bay, Ontario, Canada
Stanley Flax Medical Professional Corporation, North York, Ontario, Canada
The Fe/Male Health Centre, Oakville, Ontario, Canada
Orillia Urology Associates, Orillia, Ontario, Canada
Urotec, Oshawa, Ontario, Canada
ADA Medical Ltd., Peterborough, Ontario, Canada
AGT Research, Scarborough, Ontario, Canada
Urology & Male Infertility, Scarborough, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network Princess Margaret Hospital, Toronto, Ontario, Canada
The Male Health Centre, Toronto, Ontario, Canada
Saint Joseph Health Center, Toronto, Ontario, Canada
UroLaval, Laval, Quebec, Canada
McGill Urology Associates, Montreal, Quebec, Canada
Ultra-Med, Inc., Pointe Clare, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Centre hospitalier universitaire de Quebec, Quebec, , Canada
Uniwersytecki Szpital Kliniczny, Białystok, , Poland
Szpital Wojewódzki w Bielsku-Białej, Bielsko-Biała, , Poland
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku, Gdańsk, , Poland
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu, Inowrocław, , Poland
Szpital Miejski im. Prof. E. Michałowskiego, Katowice, , Poland
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej, Kielce, , Poland
Szpital Specjalistyczny w Kościerzynie, Kościerzyna, , Poland
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka", Kraków, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach, Pabianice, , Poland
Zakład Opieki Zdrowotnej Poznań - Stare Miasto, Poznań, , Poland
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie, Pruszków, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3, Rybnik, , Poland
Wojewódzki Szpital Specjalistyczny W Siedlcach, Siedlce, , Poland
Pomorska Akademia Medyczna, Szczecin, , Poland
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka, Słupsk, , Poland
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego, Warszawa, , Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON, Warszawa, , Poland
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń, Warszawa, , Poland
Centrum Onkologii im. Marii Skodowskiej-Curie, Warszawa, , Poland
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie, Warszawa, , Poland
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu, Wrocław, , Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy, Wrocław, , Poland
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów, Łódź, , Poland
Contact Details
Name: Shanta Chawla, MD
Affiliation: Spectrum Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
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