Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and … (NCT04681417) | Clinical Trial Compass
RecruitingPhase 2/3
Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
France225 participantsStarted 2021-03-25
Plain-language summary
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.
Who can participate
Age range
6 Months – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study 1: Rate of eye preservation
Timeframe: 24 months after randomization
2
Visual function
Timeframe: when patient is 6 years old and at least 24 months of follow-up after study inclusion
.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:
Exclusion criteria
. 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.
. Patient older than 6 years of age.
. Patients with another associated disease contra indicating systemic chemotherapy.
. Previously treated retinoblastoma by 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.