| CTRI Number |
CTRI/2020/08/027068 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
08/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical Trial Comparing instillation of Single dose Gemcitabine versus Mitomycin-C in urinary bladder after Complete Resection of urinary bladder cancer |
|
Scientific Title of Study
|
A Randomized Phase II Trial Comparing perioperative Single dose Intravesical Gemcitabine versus Mitomycin-C Following Complete Resection of Non Muscle Invasive Bladder Cancer: Evaluation of Efficacy and Tolerance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitish Aggarwal |
| Designation |
senior resident |
| Affiliation |
AIIMS ,New Delhi |
| Address |
Department of Urology
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
7986298601 |
| Fax |
|
| Email |
nitishaggarwal184@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brusabhanu Nayak |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Urology, Near NMR room
AIIMS
New Delhi
South
DELHI
110049
India |
| Phone |
9868449607 |
| Fax |
|
| Email |
brusabhanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brusabhanu Nayak |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Urology, Near NMR room,
AIIMS
New Delhi
South
DELHI
110049
India |
| Phone |
9868449607 |
| Fax |
|
| Email |
brusabhanu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Department of Urology
AIIMS
New Delhi |
| 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 |
| Brusabhanu Naik |
AIIMS, New Delhi |
Department of Urology, Near NMR room, AIIMS
New Delhi
South
DELHI |
9868449607
brusabhanu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravesical single dose Gemcitabine |
Post TURBT instillation (2000 mg) |
| Comparator Agent |
Intravesical single dose Mitomycin C |
Post TURBT instillation (40 mg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
a) Age 18 or above
b) Lesion suspicious for Non-muscle invasive bladder cancer after complete TURBT
c) General condition of the patient sufficient for 1 yr or more of follow-up (according to the attending physician)
|
|
| ExclusionCriteria |
| Details |
a) Any prior non-urothelial or muscle-invasive bladder cancer
b)History of any prior intravesical therapy for non muscle invasive bladder cancer in last
5 years
c) Intraoperative evidence of tumor in urethra or ureter
d)Suspicion of muscle invasion after complete resection
e)Previous pelvic radiotherapy for any malignancy.
f)Prior treatment for any malignancy within 5 years (other than non–muscle-invasive
bladder urothelial cancer).
g)Significant renal dysfunction (S. Cr >2)
h)Hepatic dysfunction
i)Poor performance status
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of a single dose immediate intravesical instillation of gemcitabine versus mitomycin post TURBT in preventing recurrence of completely resected non muscle invasive bladder cancer at one year. |
To determine the efficacy of a single dose immediate intravesical instillation of gemcitabine versus mitomycin post TURBT in preventing recurrence of completely resected non muscle invasive bladder cancer at one year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the toxicities between the arms. |
1 year |
| To test whether a single instillation of intravesical gemcitabine can improve the time to progression to muscle invasive disease compared to mitomycin in this patient population. |
1 year |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/08/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bladder
cancer (BC) is one of the most common urological malignancy. In about 75%,
thedisease is confined to the mucosa and lamina propria and denoted as non-muscle
invasivebladder cancer (NMIBC). The current international guidelines recommend
a single instillation of intravesical
Mitomycin
C (MMC) in the immediate postoperative period following complete transurethral
resection of the bladder tumour (TURBT). This is primarily aimed at reducing
the tumour cells implantation and prevent the recurrence. Gemcitabine has been
recently explored as single instillation intravesical chemotherapy in the
immediate postoperative period following TURBT. In the only
randomized
study, SWOG s0337 has shown that the single instillation intravesical
gemcitabine had significantly lower 4-year estimate recurrence rate as compared
to the saline irrigation for low risk tumours. Based on this study, the recent
NCCN guidelines on BC, recommends gemcitabine as preferred chemotherapeutic
agent for immediate intravesical therapy for low risk tumours. Till date
no randomized trial is available
comparing the intravesical gemcitabine with intravesical MMC which is the
current standard of practice. With this background, we designed this randomized
study comparing the single immediate instillation
of intravesical gemcitabine with intravesical MMC following complete TURBT in
patients with NMIBC in terms of safety, efficacy and tolerance.
|