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PSCI 23-020: EA8212 A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.After you finish your treatment, your doctor will continue to follow your condition for 5 years with a combination of cystoscopies (inserting a telescope in your bladder) and CT scans (to take images of your body) in order to detect cancer recurrence.
Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage)
Patient must have ECOG Performance Status 0-2.
Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization.
Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy
Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
Patient must not have pure squamous cell carcinoma or adenocarcinoma.
Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.