Phase 3 Trial Comparing Gemcitabine Plus BCG Versus BCG Alone for Recurrent High-Grade Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating the effect of adding the chemotherapy drug gemcitabine to the usual treatment with Bacillus Calmette Guerin BCG in patients who have recurrent non-muscle invasive bladder cancer NMIBC following prior BCG therapy. This phase III trial aims to compare the high-grade recurrence-free survival and other outcomes between patients receiving gemcitabine with BCG and those receiving BCG alone. The study also collects tissue and fluid samples for future research. Participants are randomly assigned to one of two treatment groups. One group receives BCG alone through a catheter into the bladder once a week for 6 weeks, followed by additional BCG treatments at months 3, 6, and 12 if there is no disease progression or unacceptable side effects. The other group receives gemcitabine and BCG alternating in a specific schedule over several weeks, with maintenance treatments at months 3, 6, and 12. Throughout treatment, patients undergo bladder biopsies, tumor resections, cystoscopies, CT or MRI scans, and blood and urine sample collections. After completing treatment, participants are followed for up to five years with visits every 3 months for two years, then every 6 months for three years. Researchers assess cancer recurrence, progression, need for bladder removal surgery, and treatment safety. The main outcome measured is the length of time patients remain free from high-grade cancer recurrence. Other outcomes include cancer-free rates at 3 and 6 months, durability of response, and adverse event rates. This long follow-up allows detailed monitoring of treatment effects and safety over time.

Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy