Actively Recruiting

Phase 2
Phase 3
Age: 6Months - 6Years
All Genders
ID04681417

Ocular Conservative Treatment for Retinoblastoma: Efficacy of New Management Strategies and Visual Outcome - RETINO 2018

Led by Institut Curie · Updated on 2025-11-28

225

Participants Needed

28

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

Institut Curie

Lead Sponsor

F

Fondation Rothschild Paris

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating new conservative treatments for retinoblastoma, a type of eye cancer affecting children. This research includes two separate studies: a randomized phase II trial testing the effectiveness of intra-arterial chemotherapy (IAC) using melphalan alone versus melphalan combined with topotecan, both alongside eye treatments; and a minimally invasive study assessing visual function after intravenous chemotherapy combined with local eye treatments or local treatment alone without chemotherapy. The goal is to improve disease control and vision outcomes in young patients with retinoblastoma. In the first study, children receive 2 to 6 monthly cycles of IAC delivered by catheter directly into the ophthalmic artery under general anesthesia. The second study involves 2 to 6 cycles of intravenous chemotherapy with etoposide, carboplatin, and vincristine, combined with eye treatments like thermotherapy, cryotherapy, iodine-125 plaques, or intravitreal melphalan injections. Both studies focus on patients with specific retinoblastoma classifications and eligibility for conservative eye management. Participants will undergo follow-up for at least 24 months, including evaluations of eye preservation rates and visual function when patients reach six years old. Researchers will monitor ocular and systemic toxicity, relapse occurrences, second cancers, retinal health, and school integration. Treatment visits, ophthalmologic assessments, and safety checks are included to track progress and outcomes over time, with a total observation period extending up to 24 months after study entry.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Months - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed retinoblastoma
  • Retinoblastoma with at least one eye eligible for conservative management
  • Likely to comply with study visits and requirements including late follow-up
  • No prior chemotherapy or radiotherapy for any cancer
  • No contraindication to proposed treatments
  • Informed consent signed by parents or legal representative
  • Covered by French Social Security
  • Children aged 6 months to 6 years (Study 1 eligibility)
  • Retinoblastoma suitable for intra-arterial chemotherapy or local treatment as defined by tumor classification (Study 1 and Study 2 criteria)
Not Eligible

You will not qualify if you...

  • Retinoblastoma not eligible for conservative management, including extra-ocular extension or certain severe tumor features
  • Patient older than 6 years
  • Other diseases preventing systemic chemotherapy
  • Previous chemotherapy treatment for retinoblastoma
  • Prior treatment for other malignant diseases
  • Psychological, familial, social, or geographical factors affecting study compliance
  • Parents not accepting the treatment after explanation
  • Contraindications to study drugs per product information
  • Participation in another experimental anti-cancer drug therapy
  • Contraindications or diseases that prevent Study 1 treatment or delay it (Study 1 specific)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 to 6 months

Participants receive intra-arterial chemotherapy (IAC) with melphalan or melphalan plus topotecan, or combined etoposide, carboplatin, and vincristine chemotherapy with local ophthalmologic treatments such as thermotherapy, cryotherapy, iodine-125 plaques, or intravitreal chemotherapy injections. Treatment cycles range from 2 to 6, spaced approximately 1 month apart, depending on tumor response.

2 to 6 monthly visits for chemotherapy cycles plus additional local treatment visits as needed

Follow-up

Duration - Up to 24 months

Participants are monitored for eye preservation, visual function, ocular and systemic toxicity, relapse, and second malignant tumors for up to 24 months after treatment completion.

Regular follow-up visits over 24 months

Trial Site Locations

Total: 28 locations

1

La Reunion - Chr Felix Guyon

Saint-Denis, La Réunion, France, 97405

Actively Recruiting

2

Amiens Chu

Amiens, France, 80054

Actively Recruiting

3

Angers Chu

Angers, France, 49033

Actively Recruiting

4

BESANCON CHU Hopital Jean Minjoz

Besançon, France, 25030

Actively Recruiting

5

Bordeaux Chu

Bordeaux, France, 33076

Actively Recruiting

6

BREST CHRU Hopital Morvan

Brest, France, 29609

Actively Recruiting

7

CAEN CHU

Caen, France, 14033

Actively Recruiting

8

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

Clermont-Ferrand, France, 63003

Actively Recruiting

9

DIJON CHU Hopital François Mitterand

Dijon, France, 21079

Actively Recruiting

10

Grenoble Chu

Grenoble, France, 38045

Actively Recruiting

11

LILLE Centre Oscar Lambret

Lille, France, 59037

Actively Recruiting

12

Limoges Chu

Limoges, France, 87042

Actively Recruiting

13

LYON Centre Léon Bérard

Lyon, France, 69373

Actively Recruiting

14

Marseille Chu

Marseille, France, 13385

Actively Recruiting

15

MONTPELLIER CHU Hopital Arnaud De Villeneuve

Montpellier, France, 34295

Actively Recruiting

16

NANTES CHU Hopital Mere-Enfant

Nantes, France, 44093

Actively Recruiting

17

NICE CHU Hopital Archet 2

Nice, France, 06202

Actively Recruiting

18

Institut Curie

Paris, France, 75005

Actively Recruiting

19

PARIS Fondation Ophtalmologique Adolphe de Rothschild

Paris, France, 75019

Actively Recruiting

20

Poitiers Chu

Poitiers, France, 86021

Actively Recruiting

21

Reims Chu

Reims, France, 51092

Actively Recruiting

22

Rennes Chu

Rennes, France, 35056

Actively Recruiting

23

Rouen Chu

Rouen, France, 76000

Actively Recruiting

24

Saint Etienne Chu

Saint-Etienne, France, 42055

Actively Recruiting

25

Strasbourg Chu

Strasbourg, France, 67098

Actively Recruiting

26

Toulouse Chu

Toulouse, France, 31026

Actively Recruiting

27

TOURS CHU Hopital Clocheville

Tours, France, 37044

Actively Recruiting

28

Nancy Chu

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

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Research Team

L

Livia LUMBROSO LE ROUIC, MD

C

Christine FOULON, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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