Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bl… (NCT00598806) | Clinical Trial Compass
CompletedPhase 3
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
United States812 participantsStarted 2007-08
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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Inclusion criteria
✓. 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 tumor 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
✕. Does the patient have more than 5 bladder tumors?
✕. Does any single bladder tumor exceed 3.5 cm in diameter?
✕. Does the patient have a single, primary bladder tumor \<0.5 cm and has no previous diagnosis of bladder cancer?
✕. Has the patient ever received EOquin(r)?
✕. Does the patient have, or has the patient ever had, any bladder tumor known to be other than tumor 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?