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New hope for kids with eye cancer: extra chemo may stop spread

NCT ID NCT02870907

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether giving chemotherapy (and sometimes radiation) after removing the eye can prevent retinoblastoma from coming back in children. About 195 children with advanced retinoblastoma in one eye took part. The goal is to see if this extra treatment reduces the chance of cancer spreading outside the eye.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 195 people

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

Started

Mar 2010

Expected to finish

Mar 2031

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

2 months to 10 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: 1. Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines; 2. Male or female ≥2 months and \<10 years of age at the time of signing the informed consent form; 3. Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation 4. In case of post operative chemotherapy, patients must have adequate organ function: * Adequate hematopoietic function Neutrophils\>1.0x109/l, Platelets \>100 x 109/l. * Adequate hepatic function: grade II NCI CTC * Adequate renal function: serum creatinemia \<1.5 x ULN for age with normal creatinine clearance estimated by SCHWARTZ formula * Audiometry \< Grade II de Brock. * Echocardiography normal in case of high dose cyclophosphamide chemotherapy (3 g/m²). 5. Patients affiliated to a Social Security Regimen or beneficiary of the same 6. No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types 7. Without medical cons-indication to study drugs. Exclusion Criteria: * Bilateral and/or familial or trilateral retinoblastoma. * Unilateral retinoblastoma with indication of primary chemotherapy before enucleation: * One or several surgical risk factors * Buphthalmia Exophthalmia. * Peri ocular inflammatory signs. * Extraocular extension : * Radiological retrolaminar extension (more than 3 mm behind the lamina cribrosa) and or meningeal sheat optic nerve extension. * Extrascleral extension * Lymp nodes extension * Unilateral retinoblastoma with possibility of conservative treatment: * Metastatic extension at diagnosis * One inclusion criteria non observed * Uncontrolled medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

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Conditions

The condition(s) this trial relates to.

retinoblastoma unilateral retinoblastoma

As listed by the trial registrant

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

Retinoblastoma

Contacts and locations

Locations

  • CHU CAEN

    Caen, 14033, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Chr Felix Guyon

    Saint-Denis, La Réunion, 97405, France

  • Chu Angers

    Angers, 49033, France

  • Chu Bocage

    Dijon, 21079, France

  • Chu Estaing

    Clermont-Ferrand, 63003, France

  • Chu Limoges

    Limoges, 87042, France

  • Chu Morvan

    Brest, 29609, France

  • Chu Nancy

    Vandœuvre-lès-Nancy, 54500, France

  • Chu Nantes

    Nantes, 44093, France

  • Chu R; Pellegrin

    Bordeaux, 33076, France

  • Chu Saint Etienne

    Saint-Etienne, 420555, France

  • Chu Toulouse

    Toulouse, 31026, France

  • Chu Tours

    Tours, 37044, France

  • Chu de Grenoble

    Grenoble, 38043, France

  • Chu de Nice

    Nice, 06202, France

  • Chu de Poitiers

    Poitiers, 86021, France

  • Chu de Rennes

    Rennes, 35056, France

  • Chu de Rouen

    Rouen, 76031, France

  • Chur de Reims

    Reims, 51100, France

  • Hopital Arnaud de Villeneuve

    Montpellier, 34295, France

  • Hopital D'Enfants La Timone

    Marseille, 13385, France

  • Hopital Jean Minioz

    Besançon, 25030, France

  • Hopital Nord Chu Amiens

    Amiens, 80054, France

  • Hoptial Hautepierre

    Strasbourg, 67098, France

  • Institut Curie

    Paris, 75005, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.