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RETINO 2018: conservative treatment for retinoblastoma: efficacy of the new management strategies and visual outcome
EU CTIS ID: 2024-514025-30-00
What this study is testing
- Study 1: To evaluate the efficacy of IAC in term of local control of the disease in patients eligible for IAC (randomized phase II study); - Study 2: To assess the visual function, based on World Health Organization (WHO) criteria, in patients eligible for other conservative treatments (IV chemotherapy in association with local ophthalmologic treatments or local ophthalmological treatment without IV chemotherapy; this is a minimally invasive interventional study).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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).
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.