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IRCT20200402046915N1 IRCT 2020-10-04 Shahid Beheshti University of Medical Sciences Assessment of the therapeutic effect of intravesical Gemcitabine in patients with bladder cancer. Assessment of the therapeutic effect of intravesical Gemcitabine compared with intravesical BCG in non-muscle invasive urothelial carcinoma of the bladder, subgroups of intermediate-risk 2020-06-21 anticipated 110 Complete https://irct.ir/trial/47954 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The 110 patients who underwent TURT were received intravesical Gemcitabine for two hours immediately after TURT surgery. Then patients were randomly divided into two groups A and B by a computer-aided program. Group A patients were treated with intravesical Gemcitabine (according to the protocol program) and Group B patients were treated with intravesical BCG. (according to the protocol program). 3 Bladder Cancer. Intervention 1: Intervention group: Patients with non-muscle invasive bladder cancer subgroup of intermediate-risk who undergo 6 intravesical injections of 1 g of vial Gemcitabine for 2 hours at one-week intervals. Intervention 2: Control group: Patients with non-muscle invasive bladder cancer subgroup of intermediate-risk who undergo 6 intravesical injections of BCG for 2 hours at one-week intervals. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome can be shared. When: Start of access period 6 months after publishing the results. To whom: Our data will only be available to researchers working in the academic centers. Conditions: Possible analyzes are performed in SPSS software. Where to obtain: Applicants should email the following e-mail address to receive the documents: sah.hojjati@sbmu.ac.ir How to obtain: The applicant can submit his / her request and receive the documents 6 months after the publication of the results via the following e-mail: sah.hojjati@sbmu.ac.ir Comments:
public Seyyed Ali Hojjati
Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8001 sah.hojjati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Seyyed Ali Hojjati
Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8001 sah.hojjati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All the patients with bladder cancer who are not candidates for chemotherapy or bladder removal surgery. Patients with no history of TURT surgery. Patients have no history of intravesical injections. Patients respond to the initial pathology under the moderate risk group with no muscle involvement. no limit no limit Both Patients with ruptured bladder during TURT surgery. Patients with immunodeficiency. Patients who are pregnant. Patients who are unable to perform TURT due to urethral stricture or urethral obstruction. Patients with a history of intravesical injections. C67.9 Malignant neoplasm of bladder, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients with non-muscle invasive bladder cancer subgroup of intermediate-risk who undergo 6 intravesical injections of 1 g of vial Gemcitabine for 2 hours at one-week intervals. Control group: Patients with non-muscle invasive bladder cancer subgroup of intermediate-risk who undergo 6 intravesical injections of BCG for 2 hours at one-week intervals. Recurrence of bladder cancer. Timepoint: First, a cystoscopy will be performed one month after the last injection into the bladder. Then, in the first year, it will be evaluated by cystoscopy every 3 months, and then every 6 months by cystoscopy. Method of measurement: Direct observation inside the bladder through cystoscopy. Shahid Beheshti University of Medical Sciences Approved 2020-07-28 Shohada Tajrish Clinical Research Development Unit Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square Tehran Tehran Iran (Islamic Republic of)