Comparing Gemcitabine and BCG for Bladder Cancer Treatment
Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study
This study is testing whether a new way of using gemcitabine can help people with intermediate and high-risk bladder cancer feel better and reduce the chances of their cancer coming back, compared to the standard treatment with BCG.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05626101 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of scheduled intravesical gemcitabine compared to intravesical BCG in patients with intermediate and high-risk non-muscle invasive bladder cancer (NMIBC). It aims to address the high recurrence rates of NMIBC following transurethral resection of bladder tumor (TURBT) by delivering high local concentrations of therapeutic agents directly into the bladder. The study includes moderate and high-risk patients who refuse radical cystectomy and excludes those with active infections or prior intravesical therapies. The goal is to improve oncological outcomes in NMIBC patients, especially in light of the BCG shortage.
Who should consider this trial
Good fit: Ideal candidates are moderate and high-risk patients with NMIBC who refuse radical cystectomy.
Not a fit: Patients with active urinary tract infections, suspected bladder perforation, or those who have previously received intravesical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative treatment for patients with NMIBC, potentially reducing recurrence rates.
How similar studies have performed: Other studies have shown promising results with intravesical therapies for NMIBC, but the specific comparison of gemcitabine to BCG is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study will include moderate and high risk patients with NMIBC. Very high risk NMIBC patients, whom refusing radical cystectomy. Exclusion Criteria: * Active UTI. * Suspected bladder perforation. * Hematuria. * Any contraindications for gemcitabin therapy; hypersenstivity, pregnancy, an infection, hemolytic uremic syndrome, , anemia, decreased blood platelets, low levels of a type of white blood cell called neutrophils. * Patients whom previously received any inravesical therapy (e.g. prior BCG).
Where this trial is running
Cairo
- Mohamed Fawzy Salman — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Fawzy Salman, MD
- Email: prof_mohamed_fawzy@yahoo.com
- Phone: +201111788996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.