Assessment of Tolerability, Response and Complications of Capecitabin added to Cisplatine for Concurrent Chemoradiation of Muscle Invasive Bladder Cancer
Determination of tolerability, Response and Complications of Capecitabin added to Cisplatine for Concurrent Chemoradiation of Muscle Invasive Bladder Cancer
Design
Patients with muscle invasive bladder cancer (T2 to T4a) TCC pathology Referred by an urologist for concurrent chemoradiation of bladder cancer.
Based on the formula for calculating the estimated prevalence of a variable ( tolerability of treatment) in a sample with an acceptable difference from the prevalence in the community (patients who endured the treatment, according to the study of RTOG 95-06, in which in 81% the treatment was completed. Approximately 23 patients would be required, including 10% falling out it would be about 25 patients.
This study will be performed as a non-randomized and single-arm, phase 1-2 clinical trial.
Settings and conduct
25 patients with TCC, stage T2-T4a, first undergo the resection of the tumor as far as possible by the transuretral resection method.The patients would be irradate to the total dose of 66 Gy in 33 fractions. Concurrently Cisplatin and Capecitabine. During the treatment Lab. Data would be checked weekly and The standard questionnaire CTCAE4.03 2010 would be filled. Three months later, cystoscopy and biopsy from the tumor bed and urine cytology would be repeated.
Participants/Inclusion and exclusion criteria
Patients with muscle invasive bladder cancer (T2 to T4a) TCC pathology; patient's refusal of radical cystectomy or not being candidate to do that due to medical comorbidities referred by an urologist for concurrent chemoradiation of bladder cancer
Intervention groups
Prescribing Capecitabine in combination with Cisplatin in concurrent chemoradiation in muscle invasive bladder cancer
Main outcome variables
Determination of tolerability and course completeness of Capecitabin added to Cisplatine for concurrent chemoradiation of muscle invasive bladder cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180815040801N1
Registration date:2019-02-06, 1397/11/17
Registration timing:retrospective
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Peiman Haddad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2567
Email address
haddad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Tolerability, Response and Complications of Capecitabin added to Cisplatine for Concurrent Chemoradiation of Muscle Invasive Bladder Cancer
Public title
The Effect of Capecitabine and Cisplatin as a Radiosensitizer in Radiation of Bladder Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with muscle invasive bladder cancer (T2 to T4a)
TCC pathology
Patient's refusal of radical cystectomy or not being candidate to do that due to medical comorbidities
Referred by an urologist for concurrent chemoradiation of bladder cancer
Exclusion criteria:
Hydronephrosis that does not resolve with usual treatments
Lymphatic or distant metastasis
Cr>2
GFR <30
WBC<3000
PLT<80,000
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam khomeini Hospital, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.4240
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
The amount of treatment tolerability and completion in adding capecitabine to cisplatin in comoradiation of muscle invasive bladder cancer
Timepoint
Weekly during treatment and three months after termination of the treatment
Method of measurement
CTCAE 4.03 2010 (Common Terminology Criteria for Adverse Events)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with muscle invasive bladder cancer at T2-T4aN0M0 stage referring to Department of Radiation Oncology Cancer Institute. In this study, 25 patients with Transitional Cell Carcinoma (TCC), stage T2-T4a who are candidates for radical cystectomy but refuse the surgery would be evaluated. First, the urologist resect the tumor as far as possible by the transuretral resection method, and then refer the patient for chemoradiation. For all the patients the standard questionnaire CTCAE4.03 2010 would be filled . The patients would be CT simulated and contoured. Then the best plan would be chosen according to contouring with the total dose of 66 Gy in 33 fractions. Concurrently Cisplatin 35 mg per m2 weekly and Capecitabine 625 mg per m2 twice a day except holidays would be prescribed. During the treatment CBC, Diff, BUN, Cr would be checked weekly. The standard questionnaire CTCAE4.03 2010 would be filled weekly, last day of radiation and 3 months after the treatmant. Three months after the end of the treatment, cystoscopy and biopsy from the tumor bed and urine cytology would be repeated. Complete clinical response is defined as the absence of a tumor in the cystoscopy, a negative biopsy of the tumor site and the absence of cells Tumor in urine cytology
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiation Oncology Department of Imam khomeini Hospital
Full name of responsible person
Sara Soltanzadeh
Street address
Radiation oncology Research Center, Cancer Institute, Imam Khomeini Hospital, Keshavarz Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
sara.soltanzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Resarch assistance of Tehran University (Dr. Mohammadali Sahraian)
Street address
Vice-chancellor of research of Tehran university, Tehran University of medical sciences, Ghods St, Keshavarz Blvd. Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8163 3620
Email
research@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sara Soltanzadeh
Position
Resident of Radiation Oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Radiation oncology Research Center, Cancer Institute, Imam Khomeini Hospital, Keshavarz Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
sara.soltanzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Peiman Haddad
Position
Professor of Radiation Oncology
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Radiation oncology Research Center, Cancer Institute, Imam Khomeini Hospital, Keshavarz Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
haddad@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Soltanzadeh
Position
Resident of Radiation Oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Radiation oncology Research Center, Cancer Institute, Imam Khomeini Hospital, Keshavarz Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
sara.soltanzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of other research maybe become at risk
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The report of study will be released.
When the data will become available and for how long
It will be after publishing the paper.
To whom data/document is available
The results will be accessible for all.
Under which criteria data/document could be used
To administer in clinical decision making the results will be accessible.
From where data/document is obtainable
To receive the results contact to correspondent.
What processes are involved for a request to access data/document