Clinical trial · Interventional
The Bladder Instillation Comparison Study
A Prospective, Open-label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor (TURBT)
NCT02695771CI-TRIAL-00065861BICcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of 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 |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Mitomycin C
- description
- Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
- interventionNames
- Drug: Mitomycin C
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- description
- Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
- interventionNames
- Drug: Gemcitabine
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. sign an informed consent for the study 2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor. Exclusion Criteria: 1. patients unable to consent for themselves 2. individuals under 18 years old 3. pregnant women 4. prisoners 5. patients with known allergy or intolerance to the mitomycin C or Gemcitabine 6. any other sound medical, psychiatric and/or social reason as determined by the investigator.
References
Publications (7)
- BACKGROUNDWeijers Y, Arentsen HC, Arends TJ, Witjes JA. Management of low-risk and intermediate-risk non-muscle-invasive bladder carcinoma. Hematol Oncol Clin North Am. 2015 Apr;29(2):219-25, vii. doi: 10.1016/j.hoc.2014.11.001. PMID 25836930
- BACKGROUNDPagano MJ, Badalato G, McKiernan JM. Optimal treatment of non-muscle invasive urothelial carcinoma including perioperative management revisited. Curr Urol Rep. 2014 Nov;15(11):450. doi: 10.1007/s11934-014-0450-1. PMID 25234184
- BACKGROUNDRoupret M, Babjuk M, Comperat E, Zigeuner R, Sylvester RJ, Burger M, Cowan NC, Bohle A, Van Rhijn BW, Kaasinen E, Palou J, Shariat SF. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Cell Carcinoma: 2015 Update. Eur Urol. 2015 Nov;68(5):868-79. doi: 10.1016/j.eururo.2015.06.044. Epub 2015 Jul 16. PMID 26188393
- BACKGROUNDSylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer: a meta-analysis of published results of randomized clinical trials. J Urol. 2004 Jun;171(6 Pt 1):2186-90, quiz 2435. doi: 10.1097/01.ju.0000125486.92260.b2. PMID 15126782
- BACKGROUNDAu JL, Badalament RA, Wientjes MG, Young DC, Warner JA, Venema PL, Pollifrone DL, Harbrecht JD, Chin JL, Lerner SP, Miles BJ; International Mitomycin C Consortium. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst. 2001 Apr 18;93(8):597-604. doi: 10.1093/jnci/93.8.597. PMID 11309436
- BACKGROUNDMontgomery JS, Miller DC, Weizer AZ. Quality indicators in the management of bladder cancer. J Natl Compr Canc Netw. 2013 Apr 1;11(4):492-500. doi: 10.6004/jnccn.2013.0061. PMID 23584349
- DERIVEDHan MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.