Comparison of two groups of anti cancer drugs for treatment of Retinoblastoma, a tumour of eye
Phase 3
Completed
- Conditions
- Health Condition 1: C692- Malignant neoplasm of retina
- Registration Number
- CTRI/2021/10/037452
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
1.Received any prior anti-neoplastic or local ophthalmic therapy
2. Group E Intraocular retinoblastoma
3. Relapsed cases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare treatment failure rate between Vincristine and Topotecan (VT) <br/ ><br>combination and Carboplatin, Etoposide and Vincristine (CEV) combination <br/ ><br>chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group <br/ ><br>D Intraocular retinoblastomaTimepoint: To compare treatment failure rate between Vincristine and Topotecan (VT) <br/ ><br>combination and Carboplatin, Etoposide and Vincristine (CEV) combination <br/ ><br>chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group <br/ ><br>D Intraocular retinoblastoma
- Secondary Outcome Measures
Name Time Method 1. To compare vision salvage in both the groups <br/ ><br>2. To compare the toxicity profile between both the groupsTimepoint: 6 months