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Hope for young eyes: study tests smarter chemo to beat eye cancer without removing the eye

NCT ID NCT04681417

Disease control Sponsor: Institut Curie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two ways to treat retinoblastoma, a childhood eye cancer, while trying to save the eye and vision. One part compares two types of artery-directed chemotherapy (one with two drugs, one with one) to see which better preserves the eye. The other part looks at how well vision is preserved with standard IV chemotherapy or local eye treatments. About 225 children with newly diagnosed retinoblastoma will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Jan 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

retinoblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinoblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amiens Chu

    RECRUITING

    Amiens, 80054, France

  • Angers Chu

    RECRUITING

    Angers, 49033, France

  • BESANCON CHU Hopital Jean Minjoz

    RECRUITING

    Besançon, 25030, France

  • BREST CHRU Hopital Morvan

    RECRUITING

    Brest, 29609, France

  • Bordeaux Chu

    RECRUITING

    Bordeaux, 33076, France

  • CAEN CHU

    RECRUITING

    Caen, 14033, France

  • CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP)

    RECRUITING

    Clermont-Ferrand, 63003, France

  • DIJON CHU Hopital François Mitterand

    RECRUITING

    Dijon, 21079, France

  • Grenoble Chu

    RECRUITING

    Grenoble, 38045, France

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • LILLE Centre Oscar Lambret

    RECRUITING

    Lille, 59037, France

  • LYON Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • La Reunion - Chr Felix Guyon

    RECRUITING

    Saint-Denis, La Réunion, 97405, France

  • Limoges Chu

    RECRUITING

    Limoges, 87042, France

  • MONTPELLIER CHU Hopital Arnaud De Villeneuve

    RECRUITING

    Montpellier, 34295, France

  • Marseille Chu

    RECRUITING

    Marseille, 13385, France

  • NANTES CHU Hopital Mere-Enfant

    RECRUITING

    Nantes, 44093, France

  • NICE CHU Hopital Archet 2

    RECRUITING

    Nice, 06202, France

  • Nancy Chu

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • PARIS Fondation Ophtalmologique Adolphe de Rothschild

    RECRUITING

    Paris, 75019, France

  • Poitiers Chu

    RECRUITING

    Poitiers, 86021, France

  • Reims Chu

    RECRUITING

    Reims, 51092, France

  • Rennes Chu

    RECRUITING

    Rennes, 35056, France

  • Rouen Chu

    RECRUITING

    Rouen, 76000, France

  • Saint Etienne Chu

    RECRUITING

    Saint-Etienne, 42055, France

  • Strasbourg Chu

    RECRUITING

    Strasbourg, 67098, France

  • TOURS CHU Hopital Clocheville

    RECRUITING

    Tours, 37044, France

  • Toulouse Chu

    RECRUITING

    Toulouse, 31026, France

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