Actively Recruiting

Phase 2
Phase 3
Age: 6Months - 6Years
All Genders
NCT04681417

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

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

225

Participants Needed

28

Research Sites

773 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

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.

CONDITIONS

Official 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...

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.
Not Eligible

You will not qualify if you...

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.

AI-Screening

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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

CONTACT

C

Christine FOULON, PhD

CONTACT

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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