Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bl… (NCT00461591) | Clinical Trial Compass
CompletedPhase 3
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
United States802 participantsStarted 2007-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: (All questions must be answered YES)
* Has the patient given written informed consent?
* Is the patient at least 18 years old?
* Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
* If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
* If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
* Is the patient willing and able to abide by the protocol?
Exclusion Criteria: (All questions must be answered NO)
* Does the patient have more than 4 bladder tumors?
* Does any single bladder tumor exceed 3.5 cm in diameter?
* Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor \<0.5 cm?
* Has the patient ever received Apaziquone?
* Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade \[WHO/ISUP classification\])?
* Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
* Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
* Does the patient have an active urinary tract infection?
* Does the patient have a bleeding disorder or a screening platelet count \< 100 x 10\^9/L?
* Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo T…