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

Launched by INSTITUT CURIE · Dec 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying new ways to treat retinoblastoma, a type of eye cancer that mostly affects young children. There are two parts to the trial. The first part is comparing two treatments: one uses a special chemotherapy delivered directly to the eye (called Intra-Arterial Chemotherapy) along with standard eye treatments, while the other uses a different chemotherapy method. The second part looks at how well patients can see after receiving standard chemotherapy through an intravenous (IV) line, combined with other eye treatments.

To participate, children aged 6 months to 6 years with newly diagnosed retinoblastoma in at least one eye that can be treated conservatively are eligible. They must not have had any previous cancer treatments and need to have the support of their parents or guardians. Participants can expect to receive specialized care and follow-up visits to monitor their progress. This trial is currently recruiting patients, aiming to find the best strategies to help children with retinoblastoma maintain their vision and manage their condition effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Overall study inclusion criteria:
• • 1. Newly diagnosed retinoblastoma (RB).
• • 2. Retinoblastoma with at least one eye eligible for conservative management.
• • 3. Patients likely to be compliant with the study requirements and visits, including late follow-up.
• • 4. Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.
• • 5. Patients with no contraindication to the proposed treatments.
• • 6. Informed consent signed by parents or legal representative.
• • 7. 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:
• • 1. 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
• • 2. 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:
• • 1. 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
• • 2. 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.
• Exclusion Criteria:
• Overall study non-inclusion criteria:
• 1. RB not eligible for conservative management :
• • 1. Extra-ocular extension of the disease, or
• • 2. Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye.
• • 2. Patient older than 6 years of age.
• • 3. Patients with another associated disease contra indicating systemic chemotherapy.
• • 4. Previously treated retinoblastoma by chemotherapy.
• • 5. Patients already treated for another malignant disease.
• • 6. Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• • 7. Patients whose parents have not accepted the treatment regimen after explanation of it.
• • 8. Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs.
• • 9. Inclusion in another experimental anti-cancer drug therapy.
• Study 1 non-inclusion criteria:
• • 10. 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.