Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
NCT ID: NCT00191477
Last Updated: 2009-10-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
355 participants
INTERVENTIONAL
2004-01-31
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
NCT00014287
Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
NCT01611662
Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma
NCT00714948
Eflornithine in Treating Patients With Bladder Cancer
NCT00003814
Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
NCT03609216
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Gemcitabine
2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
B
Placebo
intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine
2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Placebo
intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Males or females at least 18 years of age
* Karnofsky Performance Status greater than or equal to 70%
* Patient compliance and geographic proximity that allow adequate follow-up
* Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
* Signed informed consent.
Exclusion Criteria
* Clinical evidence of upper urinary tract tumor
* Distant metastases
* Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
* Severe concomitant psychiatric disease
* Febrile, active infection
* Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eli Lilly
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_CHAIR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559,1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physici
Reinfeld, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Han 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.
Bohle A, Leyh H, Frei C, Kuhn M, Tschada R, Pottek T, Wagner W, Knispel HH, von Pokrzywnitzki W, Zorlu F, Helsberg K, Lubben B, Soldatenkova V, Stoffregen C, Buttner H; S274 Study Group. Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder: a randomised, double-blind, placebo-controlled phase III multicentre study. Eur Urol. 2009 Sep;56(3):495-503. doi: 10.1016/j.eururo.2009.06.010. Epub 2009 Jun 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B9E-MC-S274
Identifier Type: -
Identifier Source: secondary_id
6138
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.