Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
Overall study 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.
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:
- 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
- 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:
- 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
- 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.
You will not qualify if you...
Overall study non-inclusion 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.
-
Patients whose parents have not accepted the treatment regimen after explanation of it.
-
Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs.
-
Inclusion in another experimental anti-cancer drug therapy.
Study 1 non-inclusion criteria:
-
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
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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