Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome

Prior treatment

• Previously treated retinoblastoma by chemotherapy.
• Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs.
• Any contraindication or concomitant disease that would preclude the Study 1 treatment procedure and could delay treatment.
  • These patients should be eligible for Study 2.

Other illness

• RB not eligible for conservative management :
  • Extra-ocular extension of the disease, or
  • Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye.
• Patients with another associated disease contra indicating systemic chemotherapy.
• Patients already treated for another malignant disease.
• Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Inclusion in another experimental anti-cancer drug therapy.
  • Study 1 non-inclusion criteria:

Age

• Patient older than 6 years of age.

Other

• Overall study non-inclusion criteria:
• Patients whose parents have not accepted the treatment regimen after explanation of it.

• 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:
  • 8.1. 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:
  • 8.2. 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.