| CTRI Number |
CTRI/2024/05/066837 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Multimodal Management of stage 2 and 3 extraocular retinoblastoma An Interventional pilot study |
|
Scientific Title of Study
|
Multimodal Management of stage II and III extraocular retinoblastoma : An Interventional pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Deep Singh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Pediatric oncology, Department of Pediatrics
Mother and child block
South
DELHI
110049
India |
| Phone |
8969607522 |
| Fax |
|
| Email |
deepshibaani@gmil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rachna Seth |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 807, 8th floor, Mother and child block, AIIMS
New Delhi
DELHI
110049
India |
| Phone |
9971188687 |
| Fax |
|
| Email |
drrachnaseth1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Deep Singh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Pediatric Oncology, Department of Pediatrics
Mother and Child Block
New Delhi
South
DELHI
110049
India |
| Phone |
8969607522 |
| Fax |
|
| Email |
deepshibaani@gmil.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, AIIMS, New Delhi -110049 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics |
| Address |
Department of Pediatrics, AIIMS, New Delhi, India- 110049 |
| Type of Sponsor |
Research institution |
|
|
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 Shivani Deep Singh |
All India Institute of medical sciences, New Delhi |
Room number 208/209/210/211, C-Wing, New RAK OPD,
Ward 5A Mother and Child Block
Division of Pediatric Oncology Department of Pediatrics
New Delhi
DELHI |
8969607522
deepshibaani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committe for postgraduate research, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C692||Malignant neoplasm of retina, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal management |
4 cycles of adjuvant Chemotherapy with Vincristine (1.5 mg/m2 on D0, D7, D14) , cyclophosphamide(1950 mg/m2 on D1, D2), Cisplatin (105 mg/m2 on D0) and Etoposide (120 mg/m2 on D1, D2) every 3 weekly
IMRT 40 Gy over 4 weeks after adjuvant chemotherapy |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Those fulfilling the criteria for IRSS stage II and III of extraocular retinoblastoma defined previously will be included in the study. |
|
| ExclusionCriteria |
| Details |
Pre-existing renal disease
Pre-existing Hearing impairment
Relapsed extraocular retinoblastoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the Disease free survival (DFS) at 1 year after multimodal management in children less than 18 years diagnosed with stage II and III extraocular retinoblastoma |
12 months after treatment completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the adverse effects using CTCAE criteria in children less
than 18 years diagnosed with stage II & III extraocular
retinoblastoma
To study the variability in interpretation of PET/CT & MRI in
management of stage II & III extraocular retinoblastoma in children
less than 18 years
To evaluate ototoxicity associated with this regimen in children less
than 18 years diagnosed with stage II & III extraocular
retinoblastoma |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/05/2024 |
| 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="6"
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
|
After applying the eligibility criteria, written informed consent shall be taken from the parent/ legally appointed representative and assent shall be taken from the child. According to the stage of disease, child will be started on Surgery versus neoadjuvant chemotherapy Child will then be taken up for enucleation. Those who will undergo upfront surgery will then be started on adjuvant chemotherapy Supportive care during and after chemotherapy administration will be optimally provided. Child will undergo external beam radiotherapy 4-6 weeks after completion of adjuvant chemotherapy. Child will then be followed up for a period of 1 year post treatment completion. |