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CTRI Number  CTRI/2024/05/067430 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of pre procedure mitomycin C inside the bladder in treatment in patients with recurrent Non invasive bladder cancer 
Scientific Title of Study   Role of neoadjuvant intravesical mitomycin C (MMC) treatment in patients with recurrent non-muscle invasive bladder cancer (NMIBC): A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swarnendu Mandal 
Designation  Associate professor 
Affiliation  AIIMS 
Address  Department of urology, room no -243, AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone    
Fax    
Email  urol_swarnendu@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Prasanna Ram 
Designation  Senior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of urology, room no -244, AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9686559576  
Fax    
Email  dr.praspr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prasanna Ram 
Designation  Senior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of urology, room no -243, AIIMS Bhubaneswar


ORISSA
751019
India 
Phone  9686559576  
Fax    
Email  dr.praspr@gmail.com  
 
Source of Monetary or Material Support  
Department of Urology, AIIMS, Sijua, Patrapada, Bhubaneswar Odisha, India 751019 
 
Primary Sponsor  
Name  AIIMS bhubaneswar 
Address  Department of Urology, AIIMS, Sijua, Patrapada, Bhubaneswar 
Type of Sponsor  Government medical college 
 
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 Prasanna Ram  All India Institute of Medical Sciences, Bhubaneswar   Department of Urology, AIIMS, Sijua, Patrapada,Bhubaneswar
Khordha
ORISSA 
9686559576

dr.praspr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECAIIMSBhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N328||Other specified disorders of bladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control arm  Patients will receive one intravesical instillation of MMC (40 mg/40 ml saline) on day: -14 and one on day: -7 + adjuvant installation of MMC after TUR resection. 
Intervention  NA MMC  Patients will receive one intravesical instillation of MMC (40 mg/40 ml saline) on day: -1 and one on day: 0 + adjuvant installation of MMC after TUR resection based on guidelines 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients with recurrent NMIBC 
 
ExclusionCriteria 
Details  1) Non-UC of the bladder
2) T2 and above tumours
3) Suspicion or presence of CIS
4) Pregnancy
5) Urinary incontinence
6) MIBC or benign disease
7) Variant histology
8) Prior intravesical MMC instillation for NMIBC within 3 y (intravesical MMC instillation within 3 y prior to study entry)
9)Prior hypersensitivity reaction history to MMC
10) Prior BCG treatment within the past 24 months
11) Neurogenic bladder
12) Untreated urinary tract infection
13) Prior systemic chemotherapy for any malignancy within 6 months
14) Any factors that would preclude study participation.
15) Withdrawal of consent at any time during the clinical trial
• No outpatient follow-up examination within 3 mo-1 y after TURBT
• Failed intravesical MMC instillation before TURBT even once due to some reasons
• Not eligible single intravesical chemotherapy instillation immediately after TURBT  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of neoadjuvant MMC treatment in reducing the recurrence rate of BC calculated as the proportion of patients who achieve a complete response (no evidence of BC after 3, 6, 12 and 24 months).  3 months
6 months
12 months
24 months 
 
Secondary Outcome  
Outcome  TimePoints 
to analyse the stage progression to MIBC in case of recurrence. 
• To look for the grade of progress 
2 weeks
3 weeks
4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   30/05/2024 
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="0"
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  

A single immediate post-TURBT instillation of intravesical MMC is well tolerated and reduces the recurrence risk to 25%-38% in patients with NMIBC by eliminating residual viable tumour cells or preventing any free-floating cancer cells during and after TURBT from reseeding2,3,4. However, the administration of intravesical MMC within 24 hours of TURBT is associated with more extensive MMC-induced trans mural necrosis/ulceration in an area of thinned muscularis propria at the base of the deep resection than the usual muscle necrosis observed after TURBT alone, resulting in secondary perforation5. Various studies have defined different intravesical MMC schedules, but definite instillation intervals and numbers in the neoadjuvant setting are yet to be defined. A recent randomized phase 2 study aiming to assess the efficacy and safety of neoadjuvant intravesical mitomycin-C in patients with NMIBC suggested that two doses of neoadjuvant intravesical mitomycin-C are safe and effective in reducing NMIBC recurrence and progression after TURBT6. Although MMC has been used in neoadjuvant settings via several administration schedules, the dose and schedule of intravesical chemotherapy for reducing the recurrence risk of NMIBC remain unknown. Another RCT noted that intravesical electromotive drug administration  (EMDA) mitomycin before TURBT is feasible and safe whilst also reducing recurrence rates and enhancing the disease-free interval when compared with intravesical passive diffusion (PD) mitomycin after TURBT and TURBT alone7. A randomized phase 2 clinical study assessing, the efficacy of a short-term intensive schedule of neoadjuvant intravesical chemotherapy in patients with recurrent NMIBC, reported that the intensive short-term schedule of neoadjuvant chemotherapy is safe and without additional toxicity when compared with the weekly regimen8. The DaBlaCa-13 Study reported that short-term, intensive chemo resection yields a tumour response of 57%, resulting in only half of those treated with chemo resection needing a TURBT, while also suggesting it has lesser clinical side effects9.

Here, we compared the feasibility and potential efficacy of 2 different regimens of intravesical MMC (IMMC) prior to TURBT, in patients with recurrent NMIBC, followed by an adjuvant instillation following the surgery.

 
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