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CTRI Number  CTRI/2025/01/079010 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Single dose of Gemcitabine versus Mitomycin C in NMIBC patients after TURBT  
Scientific Title of Study   Role of Intravesical Gemcitabine versus Mitomycin C as Immediate Intravesical Therapy post TURBT in Non-Muscle Invasive Bladder Cancer: A Prospective Exploratory Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akhilesh Sharma  
Designation  Junior Resident  
Affiliation  AIIMS Rishikesh  
Address  Level-6 Block-A Dept of Urology AIIMS Rishikesh Shivaji Nagar, Rishikesh Uttrakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9466018630  
Fax    
Email  akhileah.as@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vikas Kumar Panwar  
Designation  Associate Professor  
Affiliation  AIIMS Rishikesh  
Address  Dept of Urology Level 6 Block A AIIMS Rishikesh Shivaji Nagar, Rishikesh Uttrakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  8427040755  
Fax    
Email  vikas.uro@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Akhilesh Sharma 
Designation  Junior Resident  
Affiliation  AIIMS Rishikesh  
Address  Dept of Urology Level 6 Block A AIIMS Rishikesh Shivaji Nagar, Rishikesh Uttrakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9466018630  
Fax    
Email  akhileah.as@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh Shivaji Nagar 249203 Rishikesh Uttarakhand India 
 
Primary Sponsor  
Name  Akhilesh Sharma  
Address  AIIMS Rishikesh Shivaji Nagar, Rishikesh Uttarakhand  
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akhilesh Sharma   AIIMS Rishikesh   Department of Urology Urology Ward, Level 6 Block C AIIMS Rishikesh Shivaji Nagar, Rishikesh Uttarakhand
Dehradun
UTTARANCHAL 		 9466018630

akhileah.as@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE RELATING TO CLINICAL TRIAL AND BIOMEDICAL HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C67||Malignant neoplasm of bladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravesical Gemcitabine   Immediate single time Intravesical instillation with a hold up time of 1 hour post TURBT in the post operative period in Non-Muscle Invasive Bladder Cancer 
Comparator Agent  Intravesical Mitomycin C  Immediate single time Intravesical instillation with a hold up time of hour post TURBT in the post operative period in Non-Muscle Invasive Bladder Cancer 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  More than equal to 18 years of age
Patient providing written informed consent
Cystoscopically looking NMIBC
Cystoscopically complete resection of tumour done 
 
ExclusionCriteria 
Details  Active significant Haematuria in the post operative period
Bladder Perforation
Extensive Resection done
Previously proven MIBC patients
Any high grade or more than two low grade NMIBC in the last 18 months
Previous or concurrent upper urinary tract or prostatic urethral cancer
Pregnant or lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the recurrence rates at the end of 6 months with Intravesical Gemcitabine and Mitomycin C as Immediate Intravesical Therapy post TURBT in Non-Muscle Invasive Bladder Cancer patients.  At the end of 6 months after single dose of Intravesical Gemcitabine and Mitomycin C post TURBT in Non-Muscle Invasive Bladder Cancer patients 
 
Secondary Outcome  
Outcome  TimePoints 
To study the treatment related Adverse effects with the use of Intravesical Gemcitabine & Mitomycin C as Immediate
Intravesical Therapy post TURBT 		 Post instillation of drug on Post Operative Day One & subsequent follow up till 6 months  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   With 18.1 million new cases & around 9.6 million deaths in 2018,
cancer poses a significant disease burden worldwide. Urinary
bladder cancer in itself is 3% of the new cancer diagnoses and 2.1%
to the total cancer mortality [1].
90% of all bladder cancers are of urothelial subtype which has
tobacco smoking as the major contributing factor [2]. Several
occupations having exposure to aromatic amines (painters,
plumbers etc.), recurrent Urinary Tracts Infections, indwelling
catheters, drugs such as cyclophosphamide & environmental
exposure in the form of arsenic in drinking water are well known risk
factors for bladder cancers[2].
At presentation approximately 70% of bladder cancers are Non
Muscle Invasive Bladder Cancer (abbr. NMIBC) while others are
Muscle Invasive Bladder Cancer (abbr. MIBC) or metastatic [3]. The
typical initial management approach is cystoscopic visualisation,
followed by Trans Urethral Resection of Bladder Tumor (abbr.
TURBT). The aim of treatment in NMIBC group focuses on reducing
recurrence, preventing disease progression & minimising the
adverse events during the treatment. To prevent recurrence,
intravesical instillation of chemotherapeutic agents in the first 24
hours following TURBT is recommended and has shown favourable
results for the same. [4]
The US FDA has approved two drugs for the purpose of immediate
post-operative Intravesical Chemotherapy- Mitomycin C and
Gemcitabine, with Gemcitabine as the latest entry in the current
edition of the National Comprehensive Cancer Network (abbr.
NCCN) guidelines. Both are cytotoxic agents known to affect DNA integrity via distinctly different mechanisms.
Gemcitabine, a nucleoside analogue, undergoes efficient
phosphorylation and the resultant decrease of deoxycytidine
triphosphate further accelerates Gemcitabine nucleotide formation
and at the same time decreases their clearance via deaminase.
When incorporated into DNA, these Gemcitabine nucleotides lead to
loss of viability of the cells [5].
Mitomycin C on the other hand leads to DNA adducts formation in
cancer cells via formation of reducing equivalents leading to their
subsequent destruction [6].
Considering the current lack of literature evaluating these two drugs
when used as a single agent chemotherapy in the perioperative
period we want to conduct a prospective observational study on
Intravesical Gemcitabine versus Mitomycin C as Immediate
Intravesical Therapy in NMIBC patients undergoing TURBT to test
whether Gemcitabine provides any benefit over Mitomycin C . This
may aid in further research and clinical decision making in the future.
 
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