Ocular conservative treatment for retinoblastoma
Conditions
Brief summary
Study 1: Rate of eye preservation in the investigational arm (Topotecan + Melphalan) and in the reference arm (Melphalan) 24 months after the date of randomization., Study 2: Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension, when the patient will have 6 years of age and at least 24 months of follow-up after study inclusion.
Interventions
DRUGsolution à diluer pour perfusion
DRUGsolution injectable
DRUGMELPHALAN TILLOMED 50 mg/10 mL
Sponsors
Institut Curie
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study 1: Rate of eye preservation in the investigational arm (Topotecan + Melphalan) and in the reference arm (Melphalan) 24 months after the date of randomization., Study 2: Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension, when the patient will have 6 years of age and at least 24 months of follow-up after study inclusion. | — |
Countries
France
Outcome results
None listed