Multimodal Management of stage 2 and 3 extraocular retinoblastoma An Interventional pilot study
Phase 3
- Conditions
- Health Condition 1: C692- Malignant neoplasm of retinaHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2024/05/066837
- Lead Sponsor
- Department of Pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Those fulfilling the criteria for IRSS stage II and III of extraocular retinoblastoma defined previously will be included in the study.
Exclusion Criteria
Pre-existing renal disease
Pre-existing Hearing impairment
Relapsed extraocular retinoblastoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 retinoblastomaTimepoint: 12 months after treatment completion
- Secondary Outcome Measures
Name Time Method To study the adverse effects using CTCAE criteria in children less <br/ ><br>than 18 years diagnosed with stage II & III extraocular <br/ ><br>retinoblastoma <br/ ><br>To study the variability in interpretation of PET/CT & MRI in <br/ ><br>management of stage II & III extraocular retinoblastoma in children <br/ ><br>less than 18 years <br/ ><br>To evaluate ototoxicity associated with this regimen in children less <br/ ><br>than 18 years diagnosed with stage II & III extraocular <br/ ><br>retinoblastomaTimepoint: 1 year