| CTRI Number |
CTRI/2025/09/093985 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Intravesical instillation of Chemotherapy And Immunotherapy in patients with Bladder Cancer |
|
Scientific Title of Study
|
To determine the Efficacy and Safety of Intravesical Chemotherapy (Gemcitabine + Mitomycin C) compared with Immunotherapy (BCG) in Reducing Progression and Recurrence Among Patients with High Grade Non Muscle Invasive Bladder Cancer Post TURBT: A RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shatakshi Mishra |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai-Hallet Hospital, GSVM Medical College |
| Address |
DEPARTMENT OF GENERAL SURGERY
LLR HOSPITAL
GSVM MEDICAL COLLEGE
KANPUR
Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8853987959 |
| Fax |
|
| Email |
mshatakshi75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Kumar |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai-Hallet Hospital, GSVM Medical College |
| Address |
DEPARTMENT OF GENERAL SURGERY
LLR HALLET HOSPITAL
GSVM MEDICAL COLLEGE
KANPUR
Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9660640989 |
| Fax |
|
| Email |
vinaysinghkgmc99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shatakshi Mishra |
| Designation |
Junior Resident |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
DEPARTMENT OF GENERAL SURGERY
GSVM Medical College
Kanpur
Kanpur Nagar
UTTAR PRADESH
226010
India |
| Phone |
8853987959 |
| Fax |
|
| Email |
mshatakshi75@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM MEDICAL COLLEGE
SWAROOP NAGAR
KANPUR
UTTAR PRADESH
INDIA
PIN 208002 |
|
|
Primary Sponsor
|
| Name |
GSVM MEDICAL COLLEGE |
| Address |
SWAROOP NAGAR
KANPUR
UTTAR PRADESH
INDIA
PIN 208002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shatakshi Mishra |
GSVM MEDICAL COLLEGE |
Department of General Surgery
Lala Lajpat Rai- Hallet Hospital
Swaroop Nagar
Pin 208002
Kanpur Nagar
UTTAR PRADESH |
8853987959
mshatakshi75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravesical Chemotherapy |
Injection Gemcitabine
Injection MITOMYCIN C
-instilled weekly for 8 weeks followed by once in 3 months but should not extend beyond 1 year |
| Comparator Agent |
Intravesical Immunotherapy |
Injection Bacillus Calmette-Guerin (BCG)
-instilled weekly for 6 weeks followed by 3 weekly course done every 6 months for 3 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Confirmed Pathology Report of Ca-Bladder (Non Muscle Invasive Bladder Cancer)
-Available for whole duration of study
-Absence of Any Concomitant Upper tract Urothelial Cancer |
|
| ExclusionCriteria |
| Details |
-Presence of Lymphovascular Space Invasion or micropapillary disease
-Patients receiving systemic therapy for Ca Bladder
-Patient receiving current or prior External Beam RadioTherapy (EBRT) within 5 years
-Pregnant or Lactating Females or refusing for contraception
-Patients with symptomatic UTI or Cystitis
-Patients with Metastatic bladder cancer
-History of Malignancy of any other organ system within 5 years
-Patient who cannot hold instillation for more than 1 hour (Overactive Bladder)
-patient who cannot tolerate Intravesical dosing or surgical treatment
Are hereby, excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative study between Intravesical Chemotherapy and Immunotherapy in reducing Progression and Recurrence among patients with high grade Non Muscle Invasive Bladder Cancer |
Subjects will be assessed every 3 months with check cystourethroscopy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check for remission of Bladder tumour post commencement of intravesical therapy |
Radiological investigations (USG KUB) alongwith check Cystoscopy to be done every third month |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
02/09/2025 |
| 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="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
|
The trial involves determining the efficacy and safety of Intravesical Chemotherapy (Gemcitabine+Mitomycin C) compared with Immunotherapy (BCG) in Reducing Progression and Recurrence among patients with High grade Non Muscle Invasive Bladder Cancer. Intravesical Therapy is to be followed after patients have undergone TransUrethral Resection of Bladder Tumour and diagnosis is pathologically confirmed.
Patients are to kept in follow up with Check Cystoscopy every 3rd month to check for recurrence and/or progression. Randomization is to be done in an open label type, parallel arms.
|