| 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
|
|
|
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
|
|
|
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.Â
• 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. |