| CTRI Number |
CTRI/2024/04/065583 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative study between Chemotherapy via Arterial route in untreated verses previously treated cases of cancer of Eye in Children |
|
Scientific Title of Study
|
Super Selective Intra - Arterial Chemotherapy for Retinoblastoma - A Prospective Comparative 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 |
DR ANIKET LAXMIKANT RAMTEKE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8600219659 |
| Fax |
|
| Email |
draniketrpc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR BHAVNA CHAWLA |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room 473, 4th Floor, Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9654842424 |
| Fax |
|
| Email |
bhavna2424@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANIKET LAXMIKANT RAMTEKE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8600219659 |
| Fax |
|
| Email |
draniketrpc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi,
Ansari Nagar , 110029
|
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
AIIMS, New Delhi 110029 |
| 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 |
| DR ANIKET LAXMIKANT RAMTEKE |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi |
Ansari Nagar, New Delhi, 110029
New Delhi
DELHI |
8600219659
draniketrpc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS NEW DELHI |
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 |
Patients with Retinoblastoma who receive Intra Arterial Chemotherapy (IAC) as Secondary modality of treatment |
Patients with Retinoblastoma who receive Intra Arterial Chemotherapy (IAC) as Secondary modality of treatment.
Regimens include Single drug(Melphalan - 3, 5, or 7.5 mg), Two drug Regimen [Melphalan (3, 5, or 7.5 mg) + Topotecan (1 mg)], Three Drug regimen [Melphalan(3, 5, or 7.5 mg) + Topotecan (1 mg) + Carboplatin (30 or 50 mg)]
After every IAC cycle, patient will be followed up after 3 weeks for Evaluation under Anesthesia (EUA), and will be planned for next IAC cycle, wherever needed (upto 4-6 cycles).
After the last IAC cycle, the patient will be followed up every 4 weeks upto 6 months. |
| Intervention |
Primary Intra Arterial Chemotherapy In Retinoblastoma |
Patients with Retinoblastoma who receive Intra Arterial Chemotherapy (IAC) as primary modality of treatment.
Regimens include Single drug(Melphalan - 3, 5, or 7.5 mg), Two drug Regimen [Melphalan (3, 5, or 7.5 mg) + Topotecan (1 mg)], Three Drug regimen [Melphalan(3, 5, or 7.5 mg) + Topotecan (1 mg) + Carboplatin (30 or 50 mg)]
After every IAC cycle, patient will be followed up after 3 weeks for Evaluation under Anesthesia (EUA), and will be planned for next IAC cycle, wherever needed (upto 4-6 cycles).
After the last IAC cycle, the patient will be followed up every 4 weeks upto 6 months. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Group B/ Group C / Group D Retinoblastoma (International Classification),
Fit to undergo GA procedure, Informed Consent
|
|
| ExclusionCriteria |
| Details |
Patients Diagnosed with Group A/ Group E Retinoblastoma (International Classification), Patients with Extraocular Spread / Systemic Metastasis, Patient/ LAR Not Willing for Treatment, Patient/ LAR Not Willing for Follow Up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Globe Salvage Rate |
4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Procedure Success Rate |
4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS |
| Procedure Failure Rate |
4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS |
| Tumor Control Rate |
4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
24/04/2024 |
| 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
|
Retinoblastoma is the most common primary intraocular tumor with an incidence of 1: 16,000 to 18,000 live birth and represents 11% of cancers that develop in the first year of life. Retinoblastoma may be unilateral (60%) or bilateral (40%). Bilateral cases are heritable and median age of diagnosis is about 1 year. Unilateral cases are mostly non heritable but 15% can be heritable and median age of presentation is about 2 years.
Intra-arterial chemotherapy (IAC) is a relatively new technique for the management of advanced retinoblastoma.The Indications of IAC as Primary therapy/first-line management includes Unilateral retinoblastoma of groups B, C, and D and Bilateral retinoblastoma groups D and E. The Indications of IAC as Secondary therapy/second-line management include after prior treatment failure - Recurrent tumor, subretinal seeds or both - Persistent tumor, subretinal seeds or both.
This technique of intra-arterial chemotherapy (IAC) through ophthalmic artery has the advantage of higher concentration of chemotherapy drugs reaching the tumor, with negligible systemic side effects when compared with systemic intravenous.There are few systemic complications of IAC, including hematoma at groin entry site and transient pancytopenia from bone marrow suppression. Brain complications have been rarely encountered with carotid vascular spasm, stroke, and magnetic resonance imaging displaying focal perfusion defects. Local ocular toxicities of IAC relate mostly to vascular compromise of the ophthalmic artery, retinal artery, or choroidal vessels, cranial nerve palsy, orbit/eyelid oedema, retinal detachment, vitreous hemorrhage and retinal pigment epithelial changes. The retinal pigment epithelial changes could be related to previous retinal detachment or choroidal vascular compromise from chemotherapy toxicity.
Intra-arterial chemotherapy (IAC) for retinoblastoma involves the direct delivery of chemotherapeutic agents into the ophthalmic artery (OA). This approach is aimed at increasing drug delivery along with reduction of systemic side effects IAC has emerged as a promising option for globe salvage, particularly in advanced intraocular retinoblastoma This study will compare the outcomes of primary verses secondary Super Selective Intra-Arterial Chemotherapy in Retinoblastoma |