Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018
This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients: * Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. * Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.
‣ Overall study inclusion criteria:
⁃ Newly diagnosed retinoblastoma (RB).
⁃ Retinoblastoma with at least one eye eligible for conservative management.
⁃ Patients likely to be compliant with the study requirements and visits, including late follow-up.
⁃ Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.
⁃ Patients with no contraindication to the proposed treatments.
⁃ Informed consent signed by parents or legal representative.
⁃ French Social Security System coverage.
‣ Study 1 inclusion criteria:
• 1. Children aged from 6 months to 6 years. 9. Retinoblastoma in at least one eye, deemed manageable with IAC in one side and without IV chemotherapy:
⁃ Unilateral Retinoblastoma classified as group B, C (if vitreous seeds \< 3 mm), D or E with no invasion of the anterior segment, and without massive tumor of more than 2/3 of the eye, eligible for conservative management, or
⁃ Bilateral Retinoblastoma but with very unbalanced lesions between the two eyes: one eye group D or E without invasion of the anterior segment or massive tumor of more than 2/3 of the eye, eligible for IAC, and the other eye eligible for local treatment only (without IAC).
‣ Study 2 inclusion criteria:
• 2. Retinoblastoma eligible for conservative management although not manageable with IAC:
⁃ Unilateral Retinoblastoma in children below 6 months of age, classified as Group A, B, C or D, with or without vitreous seeding, compatible with conservative management, or
⁃ Bilateral Retinoblastoma classified as group A, B, C D, or E without invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye and eligible for conservative management.