| CTRI Number |
CTRI/2026/01/100721 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of two adjuvant treatments Gemcitabine Docetaxel and BCG for Intermediate and HighRisk Non Muscle Invasive Bladder Cancer
|
|
Scientific Title of Study
|
Intravesical Gemcitabine Docetaxel vs Bacillus Calmette Guerin A comparative study of adjuvant treatment in Intermediate and High Risk Non Muscle Invasive Bladder Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineet Bhardwaj |
| Designation |
DrNB SS Resident, Urology |
| Affiliation |
Superspeciality Hospital Government Medical College Jammu. |
| Address |
Superspeciality Hospital Government Medical College, B-5, Medical Enclave Bakshi Nagar Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9596843994 |
| Fax |
|
| Email |
vineet22418@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elias Sharma |
| Designation |
Professor and Head of Department, Urology |
| Affiliation |
Superspeciality Hospital Government Medical College Jammu. |
| Address |
Superspeciality Hospital Government Medical College, B-5, Medical Enclave Bakshi Nagar Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
7006705101 |
| Fax |
|
| Email |
eliassharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vineet Bhardwaj |
| Designation |
DrNB SS Resident, Urology |
| Affiliation |
Superspeciality Hospital Government Medical College Jammu. |
| Address |
Superspeciality Hospital Government Medical College, B-5, Medical Enclave Bakshi Nagar Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9596843994 |
| Fax |
|
| Email |
vineet22418@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GMC Jammu |
| Address |
Super Speciality Hospital Government Medical College, B-5 Medical Enclave, Bakshi Nagar Jammu |
| 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 Elias Sharma |
Super Speciality Hospital |
Superspeciality Hospital Government Medical College, B-5, Medical Enclave Bakshi Nagar Jammu
Jammu
JAMMU & KASHMIR |
7006705101
eliassharma@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMCJ |
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 |
| Comparator Agent |
Intravesical instillation of injection BCG |
Injection BCG 80 mg Intravesical administration to be retained for 90 minutes.
Treatment will be started 4 weeks after transurethral resection of bladder tumor.
Induction dose once weekly for 6 weeks followed by 3 weekly maintenance instillations at 3 months, 6 months, and then every 6 months up to 2 years.
|
| Intervention |
Intravesical sequential instillation of injection Gemcitabine and Docetaxel |
Injection Gemcitabine 1g + Docetaxel 40mg sequential intravesical administration each drug to be retained for 90 minutes.
Treatment will be started 4 weeks after transurethral resection of bladder tumor.
Induction dose once weekly for 6 weeks followed by monthly maintenance dose for 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with histopathology reported non muscle invasive bladder cancer falling under category of intermediate and high risk NMIBC as per AUA Guidelines will be included in the study group.
Patients will be included only after valid informed written consent for the study
Adult patients above 18 yr and less than or equal to 80 years will be included.
Both male and female patients will be included.
|
|
| ExclusionCriteria |
| Details |
Patients not giving consent to be the part of study.
Patients with muscle invasive bladder cancer.
Pregnant and lactating females.
Age less than 18 years or more than 80 years.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence-free survival at 24 months |
Base line assessment with Cystoscopy at initiation of therapy followed by Cystoscopy at 3rd month, 6th month 9th month, 12th month, 15th month, 18th month, and 24th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events & Patient-reported QoL scores |
Patients will be assessed at the time of drug administration & on followup basis at 3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21st month & 24th month. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
19/01/2026 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This Randomized controlled open labelled trial aims to compare adjuvant intravesical treatment of non muscle invasive urinary bladder cancer falling under intermediate and high risk group according to latest AUA guidelines using sequential Gemcitabine docetaxel administration vs Standard BCG therapy in terms of recurrence free survival and side effect profile, tolerance to treatment and treatment discontinuation rates. In the era of global BCG Shortage and looking into the side effect profile and treatment discontinuation rates of patients recieveing BCG , this trial , if proven that GEMDOCE treatment is comparable or better than BCG , can aid in management of such patients as a standarized treatment. |