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CTRI Number  CTRI/2022/02/040185 [Registered on: 10/02/2022] Trial Registered Prospectively
Last Modified On: 07/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Use of controlled heated intravesical chemotherapy in urinary bladder cancer 
Scientific Title of Study   Pilot study to evaluate safety and efficacy of single postoperative HIVEC after TURBT. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
N/A  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amitabh Singh 
Designation  Consultant 1 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini

North West
DELHI
110085
India 
Phone  01147022065  
Fax    
Email  amitabhsingh27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amitabh Singh 
Designation  Consultant 1 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini

North West
DELHI
110085
India 
Phone  01147022065  
Fax    
Email  amitabhsingh27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amitabh Singh 
Designation  Consultant 1 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini

North West
DELHI
110085
India 
Phone  01147022065  
Fax    
Email  amitabhsingh27@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi 110085 
 
Primary Sponsor  
Name  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Sector 5, Rohini, Delhi 110085 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amitabh Singh  Rajiv Gandhi Cancer Institute and Research Centre  Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini
North West
DELHI 
01147022065

amitabhsingh27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N329||Bladder disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyperthermic intravesical mitomycin  Postoperative HIVEC will be given in all risk group within 24 hours of TURBT, preferably within 6 hours of TURBT.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Post-operative hyperthermic intravesical mitomycin will be given in all patients of non muscle invasive bladder cancer. 
 
ExclusionCriteria 
Details  1. Patient having:
- gross hematuria
- bladder perforation
- muscle invasive disease

2. Patient not willing to sign consent for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of adverse events  Adverse events which occur within 30 days after the study intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
to assess Recurrence free survival, Progression free survival  Every 3 monthly. 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Carcinoma urinary bladder is most common urothelial cancer of urinary tract. Carcinoma urinary bladder is notorious for its high recurrence rates. Single dose of intravesical mitomycin in postoperative period has been recommended to reduce recurrence rate in patients of low and intermediate risk disease. The biologic rational for delivery of single postoperative dose of intravesical chemotherapy is based on the antitumor effects against tumor cells suspended in the bladder and residual tumor cells at the base of the resection bed following TURBT. Contemporary meta-analysis of randomized trials including 2278 patients reported a risk of recurrence reduction by 35% [hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.58–0.77, p < 0.001] and absolute risk reduction of 14% at 5 years. So, guideline recommendations support the use of a single postoperative intravesical dose of chemotherapy [e.g.: mitomycin C (MMC) or epirubicin] immediately after TURBT for patients with low-risk NMIBC.

 Hyperthermic intravesical chemotherapy is a new technique, where mitomycin is given into urinary bladder at temperature of 41 - 43°C. Investigators reported significant improvement in disease control for high and intermediate risk disease in comparison to mitomycin. 

 Hyperthermic intravesical mitomycin has not been studied in postoperative setting, whereas mitomycin has been already in use in postoperative setting with proven efficacy. In view of better efficacy of HIVEC in comparison to mitomycin, we propose better oncological results with HIVEC in immediate postoperative setting. 

 

 
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