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
Prevent recurrence of bladder cancer in patients with non-muscle invasive bladder cancer subgroup of intermediate-risk by using intravesical Gemcitabine.
Design
Randomized clinical trial with a control group, two parallel-group, not blind on 110 patients
Settings and conduct
The study will perform on patients with bladder masses who referred to Shohada-e Tajrish Hospital who had no history of TURT surgery. Immediately after TURT, intravesical injection of Gemcitabine is performed for all patients. Patients whose pathology is non-muscle invasive and are in the intermediate-risk subgroup are included in the study. Patients will be randomly divided into two groups by computer. The sample size of each group will be 55 according to statistical calculations. This trial will have a control group and will not be blind. The first group undergoes 6 intravesical injections of Gemcitabine at intervals of one week. The second group undergoes 6 intravesical BCG injections at intervals of one week. Then, according to the guideline protocol, patients undergo cystoscopy at regular intervals and are examined for tumor recurrence.
Participants/Inclusion and exclusion criteria
Patients with non-muscle invasive bladder cancer, the subgroup of intermediate-risk will enter the study. Patients should not have the history of using intravesical injections. Patients should not have a history of previous TURT. Pregnant women and patients with immunodeficiency conditions and also patients who have ruptured during TURT, will exclude.
Intervention groups
Intravesical injection of Gemcitabine 6 times with one-week intervals In the intervention group and injection of intravesical BCG 6 times with one-week intervals in the control group
Main outcome variables
Tumor recurrence is the main consequence of the study, which will evaluate by cystoscopy in predetermined follow-up.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200402046915N1
Registration date:2020-10-04, 1399/07/13
Registration timing:registered_while_recruiting
Last update:2020-10-04, 1399/07/13
Update count:0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
Seyyed Ali Hojjati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2282 9356
Email address
sah.hojjati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Assessment of the therapeutic effect of intravesical Gemcitabine in patients with bladder cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
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)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shohada Tajrish Clinical Research Development Unit
Street address
Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.507
Health conditions studied
1
Description of health condition studied
Bladder Cancer
ICD-10 code
C67.9
ICD-10 code description
Malignant neoplasm of bladder, unspecified
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish hospital
Full name of responsible person
Seyyed Ali Hojjati
Street address
Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Email
sah.hojjati@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti Medical University , Near the Taleghani Hospital , Yaman Street , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Hojjati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Email
sah.hojjati@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Hojjati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Email
sah.hojjati@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Hojjati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital , Shahrdari Street , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Email
sah.hojjati@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome can be shared.
When the data will become available and for how long
Start of access period 6 months after publishing the results.
To whom data/document is available
Our data will only be available to researchers working in the academic centers.
Under which criteria data/document could be used
Possible analyzes are performed in SPSS software.
From where data/document is obtainable
Applicants should email the following e-mail address to receive the documents:
sah.hojjati@sbmu.ac.ir
What processes are involved for a request to access data/document
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