AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients able to consent in English or Spanish; provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female ages ≥18 years.
✓. Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
✓. Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG.
Exclusion criteria
✕. Known hypersensitivity reaction to gemcitabine and/or docetaxel.
✕. Clinical T2 or higher stage UC of the bladder.
✕. Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.
What they're measuring
1
Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC
Timeframe: Complete response rate will be measured at the 3-month visit
. Active malignancies other than the disease being treated under study.
✕. Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
✕. Pregnant or breast-feeding women.
✕. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.