Clinical trial · Interventional
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progression rate. The aim of this research is to evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of high-risk superficial bladder cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG | Drug | — | UNRESOLVED |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Group A received BCG instillation 14 days after II look-TURB:6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.
- interventionNames
- Drug: BCG
- type
- EXPERIMENTAL
- label
- 2
- description
- 14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
- interventionNames
- Drug: gemcitabine
Primary outcomes (1)
- measure
- The primary outcome measure consists of evaluation of recurrence and progression rates as they were detected by follow-up tools. Interval before recurrence and progression were also considered primary end-points
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Primary diagnosis of high risk superficial bladder cancer according to EAU guidelines (http://www.eortc.be/tools/bladdercalculator/), * Having never been treated with other intravesical chemotherapeutic agents, * And to consent to participate to the study Exclusion Criteria: * Concomitant tumours; * Urinary tract infections (UTI); * Altered function of the liver, kidneys and/or bone marrow; * Major cardiovascular diseases; * Life expectancy of less than 1 year; * Intravesical chemotherapy in the previous 3 months or immunotherapy in the previous 6 months; * Systemic chemotherapy and pelvic radiotherapy prior to TURB, and any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
References
Publications (0)
Data not yet available