RETINO 2018: conservative treatment for retinoblastoma: efficacy of the new management strategies and visual outcome

Phase 1

Conditions: Ocular conservative treatment for retinoblastoma
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-514025-30-00

Lead Sponsor: Institut Curie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 225

Inclusion Criteria

Overall study inclusion criteria: Newly diagnosed RB., Study 2 inclusion criteria: RB eligible for conservative management although not manageable with IAC: a. Unilateral RB 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 b. Bilateral RB 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., Overall study inclusion criteria: RB with at least one eye eligible for conservative management, Overall study inclusion criteria: Patients likely to be compliant with the study requirements and visits, including late follow-up., Overall study inclusion criteria: Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer., Overall study inclusion criteria: Patients with no contraindication to the proposed treatments., Overall study inclusion criteria: Informed consent signed by parents or legal representative, Overall study inclusion criteria: French Social Security System coverage., Study 1 inclusion criteria:Children aged from 6 months to 6 years., Study 1 inclusion criteria: RB in at least one eye, deemed manageable with IAC in one side and without IV chemotherapy: a. Unilateral RB 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 b. Bilateral RB 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).

Exclusion Criteria

Overall study non-inclusion criteria: RB not eligible for conservative management : a. Extra-ocular extension of the disease, or b. Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye., Study 1 non-inclusion criteria: Any contraindication or concomitant disease that would preclude the Study 1 treatment procedure and could delay treatment., Overall study non-inclusion criteria: Patient older than 6 years of age., Overall study non-inclusion criteria:Patients with another associated disease contra indicating systemic chemotherapy., Overall study non-inclusion criteria: Previously treated retinoblastoma by chemotherapy, Overall study non-inclusion criteria: Patients already treated for another malignant disease, Overall study non-inclusion criteria: Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule., Overall study non-inclusion criteria: Patients whose parents have not accepted the treatment regimen after explanation of it., Overall study non-inclusion criteria: Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs, Overall study non-inclusion criteria: Inclusion in another experimental anti-cancer drug therapy