| CTRI Number |
CTRI/2021/10/037452 [Registered on: 21/10/2021] Trial Registered Prospectively |
| Last Modified On: |
10/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two groups of anti cancer drugs for treatment of Retinoblastoma, a tumour of eye |
|
Scientific Title of Study
|
Vincristine and Topotecan versus Carboplatin, Etoposide and Vincristine based chemotherapy for ocular salvage in Gr D Intraocular Retinoblastoma: a randomised, open label trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Prabhakar |
| Designation |
DM Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Division of Pediatric oncology
Department of Pediatrics
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8800719116 |
| Fax |
|
| Email |
prashant15prabhakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashant Prabhakar |
| Designation |
DM Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Division of Pediatric oncology
Department of Pediatrics
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8800719116 |
| Fax |
|
| Email |
prashant15prabhakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Rachna Seth |
| Designation |
Professor and chief |
| Affiliation |
AIIMS New Delhi |
| Address |
Division of Pediatric oncology
Department of Pediatrics
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9971188687 |
| Fax |
|
| Email |
drrachnaseth1967@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Division of Pediatric oncology
Department of Pediatrics
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 |
| Prashant Prabhakar |
AIIMS New Delhi |
Division of Paediatric Oncology
Department of Paediatrics
Room no C5 Day care
South
DELHI |
8800719116
prashant15prabhakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C692||Malignant neoplasm of retina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carboplatin,Etoposide,vincristine |
Chemotherapy will be given for 6 cycles.The duration of each cycle is 5 days and it will be repeated every 21 days. Total duration of study is 2 years |
| Intervention |
Vincristine,Topotecan |
Chemotherapy agents will be given for 6 cycles. The duration of each cycle is 5 days and it will be repeated every 21 days. Total duration of study is 2 years |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.All cases of newly diagnosed Unilateral Group D Intraocular Retinoblastoma
2. All cases of newly diagnosed bilateral Intraocular Retinoblastoma with at least one
eye with Group D Intraocular Retinoblastoma
3. Age less than 12 years |
|
| ExclusionCriteria |
| Details |
1.Received any prior anti-neoplastic or local ophthalmic therapy
2. Group E Intraocular retinoblastoma
3. Relapsed cases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare treatment failure rate between Vincristine and Topotecan (VT)
combination and Carboplatin, Etoposide and Vincristine (CEV) combination
chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group
D Intraocular retinoblastoma |
To compare treatment failure rate between Vincristine and Topotecan (VT)
combination and Carboplatin, Etoposide and Vincristine (CEV) combination
chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group
D Intraocular retinoblastoma |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare vision salvage in both the groups
2. To compare the toxicity profile between both the groups |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2021 |
| Date of Study Completion (India) |
31/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
patients will be divided into two groups based on randomisation and they will receive one of the two treatment arms based on allocation. after two cycles of chemotherapy they will undergo evaluation under anaesthesia to look for tumour regression. After 6 cycles of chemotherapy children in both group will be compared for ocular salvage and toxicity |