| CTRI Number |
CTRI/2022/02/040185 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
07/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of controlled heated intravesical chemotherapy in urinary bladder cancer |
|
Scientific Title of Study
|
Pilot study to evaluate safety and efficacy of single postoperative HIVEC after TURBT. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amitabh Singh |
| Designation |
Consultant 1 |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini
North West DELHI 110085 India |
| Phone |
01147022065 |
| Fax |
|
| Email |
amitabhsingh27@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amitabh Singh |
| Designation |
Consultant 1 |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini
North West DELHI 110085 India |
| Phone |
01147022065 |
| Fax |
|
| Email |
amitabhsingh27@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amitabh Singh |
| Designation |
Consultant 1 |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini
North West DELHI 110085 India |
| Phone |
01147022065 |
| Fax |
|
| Email |
amitabhsingh27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Centre,
Sector 5, Rohini, Delhi 110085 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Sector 5, Rohini, Delhi 110085 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amitabh Singh |
Rajiv Gandhi Cancer Institute and Research Centre |
Department of GenitoUro Oncology, Room No. 3177, 1st Floor, D-Block, Sector 5, Rohini North West DELHI |
01147022065
amitabhsingh27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N329||Bladder disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperthermic intravesical mitomycin |
Postoperative HIVEC will be given in all risk group within 24 hours of TURBT, preferably within 6 hours of TURBT. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Post-operative hyperthermic intravesical mitomycin will be given in all patients of non muscle invasive bladder cancer. |
|
| ExclusionCriteria |
| Details |
1. Patient having:
- gross hematuria
- bladder perforation
- muscle invasive disease
2. Patient not willing to sign consent for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events |
Adverse events which occur within 30 days after the study intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess Recurrence free survival, Progression free survival |
Every 3 monthly. |
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
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)
|
15/02/2022 |
| 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="6" 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
|
Carcinoma urinary bladder is most common urothelial cancer of urinary tract. Carcinoma urinary bladder is notorious for its high recurrence rates. Single dose of intravesical mitomycin in postoperative period has been recommended to reduce recurrence rate in patients of low and intermediate risk disease. The biologic rational for delivery of single postoperative dose of intravesical chemotherapy is based on the antitumor effects against tumor cells suspended in the bladder and residual tumor cells at the base of the resection bed following TURBT. Contemporary meta-analysis of randomized trials including 2278 patients reported a risk of recurrence reduction by 35% [hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.58–0.77, p < 0.001] and absolute risk reduction of 14% at 5 years. So, guideline recommendations support the use of a single postoperative intravesical dose of chemotherapy [e.g.: mitomycin C (MMC) or epirubicin] immediately after TURBT for patients with low-risk NMIBC. Hyperthermic intravesical chemotherapy is a new technique, where mitomycin is given into urinary bladder at temperature of 41 - 43°C. Investigators reported significant improvement in disease control for high and intermediate risk disease in comparison to mitomycin. Hyperthermic intravesical mitomycin has not been studied in postoperative setting, whereas mitomycin has been already in use in postoperative setting with proven efficacy. In view of better efficacy of HIVEC in comparison to mitomycin, we propose better oncological results with HIVEC in immediate postoperative setting. |