Health Condition 1: C692- Malignant neoplasm of retina Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: 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
Sponsors
Department of Pediatrics
Eligibility
Inclusion criteria
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
Exclusion criteria: Pre-existing renal disease Pre-existing Hearing impairment Relapsed extraocular retinoblastoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 retinoblastomaTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactShivani Deep Singh
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed