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Comparison of two groups of anti cancer drugs for treatment of Retinoblastoma, a tumour of eye

Vincristine and Topotecan versus Carboplatin, Etoposide and Vincristine based chemotherapy for ocular salvage in Gr D Intraocular Retinoblastoma: a randomised, open label trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037452
Enrollment
60
Registered
2021-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C692- Malignant neoplasm of retina

Interventions

Intervention1: 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 Con

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1.Received any prior anti-neoplastic or local ophthalmic therapy 2. Group E Intraocular retinoblastoma 3. Relapsed cases

Design outcomes

Primary

MeasureTime frame
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 retinoblastomaTimepoint: 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

MeasureTime frame
1. To compare vision salvage in both the groups 2. To compare the toxicity profile between both the groupsTimepoint: 6 months

Countries

India

Contacts

Public ContactProf Rachna Seth

AIIMS New Delhi

prashant15prabhakar@gmail.com8800719116

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026