Retinoblastoma Cancer
Conditions
Interventions
Participating children will be allocated by chance to a new chemotherapy treatment combination (topotecan and cyclophosphamide) OR the standard three-drug combination (vincristine, etoposide and carbo
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children presenting with stage 2 or stage 3 retinoblastoma in Tanzania
Exclusion criteria
Exclusion criteria: 1. Patients with pre-existing chronic illnesses which require treatment may impact on the ability to tolerate chemotherapy or radiotherapy 2. Patients with a history of prior treatment 3. Patients with suspected or documented life-threatening infections (should be established before enrolment) 4. Patients with stage 3 disease who are enucleated up front
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to survival from randomization (months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival measured over 2-year follow up 2. Event-free survival. Events will be defined as: 2.1. Death (disease, treatment related or other) 2.2. Resistant disease (defined as unresectable tumors following neo-adjuvant chemotherapy) 2.3. Local, CNS or other distant relapses (defined as disease considered related to this presentation which returns after an initial response to treatment assessment confirmed a complete response) 2.4. Recurrent disease (defined as a new tumor deemed unrelated to the first disease, including disease beginning in the fellow eye or a tumor appearing at a new retinal site) 3. Treatment toxicity: 3.1. Bone marrow suppression: anaemia, (febrile) neutropenia, thrombocytopenia 3.2. Gastro-intestinal effects include vomiting, anorexia and resulting malnutrition, constipation 3.3. Etoposide infusion related hypotension 3.4. Hearing loss All harms that will be observed during the study will be reported including resistant disease, local CNS or distant relapse, as well as recurrent disease. Standard CTCAE grading will be used to assess and collect adverse events. All adverse events will be reported to NIMR per protocol. Patients with adverse events will be monitored with weekly lab until return to baseline. Standard prophylactic and supportive care protocols will be implemented, including use of antibiotics for fever and neutropenia during the care for patients with adverse events. Events and harms will be recorded at all points of the treatment programme and during and standardized follow-up procedure for 2 years post randomization. | — |
Countries
Tanzania
Contacts
Public ContactRichard Bowman
Outcome results
None listed