Health Condition 1: C692- Malignant neoplasm of retina
Conditions
Interventions
Intervention1: Vincristin topotecan chemotherapy: Children less than 18 years age diagnosed with unilateral or bilateral group A, B or C retinoblastoma will be treated with systemic vincristine topote
Sponsors
The Gujarat Cancer and Research Institution
Eligibility
Inclusion criteria
Inclusion criteria: Children less than 18 years of age newly diagnosed with unilateral or bilateral Intra-ocular (stage-0) group A, B and/or C disease with In case of bilateral retinoblastoma the other eye being either group A, B or C disease requiring no chemotherapy or vincristine topotecan chemotherapy or group D or E enucleated disease not requiring post enucleation chemotherapy Not previously treated with any form of chemotherapy including intravitreal, intra-arterial or systemic chemotherapy Adequate liver and renal function at diagnosis (total bilirubin, AST, ALT and serum creatinine less than 3 times upper limit of normal for age and sex)
Exclusion criteria
Exclusion criteria: 1. Any of the eye having group D, E disease requiring upfront or post-enucleation chemotherapy other than vincristine-topotecan RBM25 protocol 2. The other eye with extraocular disease 3. Presence of metastatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (EFS) at 2 years is the primary outcome. Events for EFS will be change of chemotherapy anytime for any reasons, enucleation or use of radiotherapyTimepoint: 2 years EFS will be calculated | — |
Secondary
| Measure | Time frame |
|---|---|
| Event for overall survival (OS) will be death due to any cause. 2. Ocular survival (ocular salvage)Timepoint: two year | — |
Countries
India
Contacts
Public ContactMaharshi Trivedi
The Gujarat Cancer and Research Institute
Outcome results
None listed