Actively Recruiting
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
Eligibility Criteria
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)
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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