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Clinical Trial NCT04681417 (RETINO 2018) for Retinoblastoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome (RETINO 2018)
Clinical Trial NCT04681417 (RETINO 2018) is designed to study Treatment for Retinoblastoma. It is a Phase 2 Phase 3 interventional trial that is recruiting, having started on 25 March 2021, with plans to enroll 225 participants. Led by Institut Curie, it is expected to complete by 20 January 2036. The latest data from ClinicalTrials.gov was last updated on 28 November 2025.
Brief Summary
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.
Detailed Description
Primary objective of the studies:
- Study 1: To evaluate the efficacy of IAC in term of local control of the disease in patients eligible for IAC (randomized phase II study);
- Study 2: To assess the visual function, based on World Health Organization (WHO) criteria, in patients eligible for other conservative treatments (IV chemotherapy in association with local ophthalmologic trématent or local ophthalmological treatment without IV chemotherapy; this is a minimally invasive interventional study).
Official Title
Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018
Conditions
RetinoblastomaOther Study IDs
- RETINO 2018
- IC 2019-05
NCT ID Number
Start Date (Actual)
2021-03-25
Last Update Posted
2025-11-28
Completion Date (Estimated)
2036-01-20
Enrollment (Estimated)
225
Study Type
Interventional
PHASE
Phase 2
Phase 3
Phase 3
Status
Recruiting
Keywords
Pediatric
Ocular conservative treatment in retinoblastoma
Ocular conservative treatment in retinoblastoma
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalStudy 1: Melphalan or Melphalan + Topotecan 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. | Melphalan or Melphalan + Topotecan IAC: 2-6 cycles every 1 month (number based on the local tumor evolution), performed using radio-guided catheterization and delivery at the ostium of the ophthalmic artery, in neuroradiology operating room, and under General Anesthesia (GA). IAC will be administered at the Fondation Rothschild Hospital in collaboration with the Interventional Neuroradiology team. Thermotherapy (Local Treatment) Thermotherapy after carboplatin administered on Day 1 Cryotherapy (Local Treatment) Cryotherapy (local treatment) IODINE-125 Plaques (Local Treatment) Iodine-125 plaques (local treatment) Intravitreal Melphalan Chemotherapy Injections (Local Treatment) Intravitreal Melphalan chemotherapy injections (local treatment) |
OtherStudy 2: Etoposide, carboplatin and vincristine Neoadjuvant chemotherapy involves 2 to 6 cycles of combined etoposide, carboplatin and vincristine in association with ophthalmologic treatments. | Etoposide, Carboplatin and Vincristine or Local Ophthalmological Treatment Without IV Chemotherapy 2 to 6 cycles of combined etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy : thermotherapy and/or cryotherapy and/or iodine-125 plaques and/or intravitreal chemotherapy injections Carboplatin Administered on Day 1 Chemothermotherapy : Intravenous injection by carboplatin Thermotherapy (Local Treatment) Thermotherapy after carboplatin administered on Day 1 Cryotherapy (Local Treatment) Cryotherapy (local treatment) IODINE-125 Plaques (Local Treatment) Iodine-125 plaques (local treatment) Intravitreal Melphalan Chemotherapy Injections (Local Treatment) Intravitreal Melphalan chemotherapy injections (local treatment) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Study 1: Rate of eye preservation | Rate of eye preservation in the 2 treatments' arms | 24 months after randomization |
Visual function | Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension | when patient is 6 years old and at least 24 months of follow-up after study inclusion |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Ocular toxicity | Percentage of patients with at least one grade-3 or -4 toxicity (CTCAE v. 5.0) | Up to 24 months after inclusion in the study |
Systemic toxicity | Rate of specific grade 3-4 toxicity (CTCAE v. 5.0) | Up to 24 months after inclusion in the study |
Relapse | Percentage of patients with relapse within 24 months after inclusion, broken down into: Local relapse, Extra-ocular relapse | within 24 months after inclusion |
Second malignant tumor | Percentage of patients with second malignant tumor within 24 months after study inclusion | 24 months after study inclusion |
Additional assessment of visual function | Additional assessment of visual function at follow-up: Percentage of patients at each of the four levels of visual acuity according to WHO criteria | In the year patients turn 6 years of age and at least 24 months of treatment |
Retinal assessment | Optical Coherence Tomography (OCT) and Optical Coherence Tomography-Angiography (OCT-A) measures on retina | In the year patients turn 6 years of age and at least 24 months of treatment |
Integration at school | Rate of children able to attend the common primary school : without specific help or with the help of a dedicated person and/or with specific features to facilitate reading and writing | In the year patients turn 6 years of age and at least 24 months of treatment |
Eligibility Criteria
Eligible Ages
Child
Minimum Age
6 Months
Eligible Sexes
All
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.
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.
Institut CurieFondation Rothschild ParisStudy Central Contact
Contact: Livia LUMBROSO LE ROUIC, MD, +33(0)144324163, [email protected]
Contact: Christine FOULON, PhD, +33(0)147111733, [email protected]
28 Study Locations in 1 Countries
La Réunion
La Reunion - Chr Felix Guyon, Saint-Denis, La Réunion, 97405, France
Yves REGUERRE, MD, Contact, 26(2)262905676, [email protected]
Yves REGUERRE, MD, Principal Investigator
Recruiting
Amiens Chu, Amiens, 80054, France
Camille KHANFARD, MD, Contact, +33(0)322087650, [email protected]
Camille KHANFARD, MD, Principal Investigator
Recruiting
Angers Chu, Angers, 49033, France
Isabelle PELLIER, MD, Contact, +33(0)241353863, [email protected]
Isabelle PELLIER, MD, Principal Investigator
Recruiting
BESANCON CHU Hopital Jean Minjoz, Besançon, 25030, France
Sébastien KLEIN, MD, Contact, +33(0)381219212, [email protected]
Sébastien KLEIN, MD, Principal Investigator
Recruiting
Bordeaux Chu, Bordeaux, 33076, France
Céline DE BOUYN ICHER, MD, Contact, +33(0)557820434, [email protected]
Céline DE BOUYN ICHER, MD, Principal Investigator
Recruiting
BREST CHRU Hopital Morvan, Brest, 29609, France
Liana-Stéphania CARAUSU, MD, Contact, (+33) 02 98 22 37 70, [email protected]
Liana-Stéphania CARAUSU, MD, Principal Investigator
Recruiting
CAEN CHU, Caen, 14033, France
Damien BODET, MD, Contact, +33(0)231064488, [email protected]
Damien BODET, MD, Principal Investigator
Recruiting
CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP), Clermont-Ferrand, 63003, France
Justyna KANOLD, MD, Contact, (+33) 04 73 75 00 09, [email protected]
Justyna KANOLD, MD, Principal Investigator
Recruiting
DIJON CHU Hopital François Mitterand, Dijon, 21079, France
Claire BRIANDET, MD, Contact, +33(0)380293601, [email protected]
Claire BRIANDET, MD, Principal Investigator
Recruiting
Grenoble Chu, Grenoble, 38045, France
Anne PAGNIER, MD, Contact, 04 76 76 58 93, [email protected]
Anne PAGNIER, MD, Principal Investigator
Recruiting
LILLE Centre Oscar Lambret, Lille, 59037, France
Hélène SUDOUR BONNANGE, MD, Contact, +33(0)320295959, [email protected]
Hélène SUDOUR BONNANGE, MD, Principal Investigator
Recruiting
Limoges Chu, Limoges, 87042, France
Christophe PIGUET, MD, Contact, +33(0)555056801, [email protected]
Christophe Christophe PIGUET, MD, Principal Investigator
Recruiting
LYON Centre Léon Bérard, Lyon, 69373, France
BENOIT DUMONT, MD, Contact, [email protected]
Contact, +33 (0)4 69 16 65 74
BENOIT DUMONT, MD, Principal Investigator
Recruiting
Marseille Chu, Marseille, 13385, France
Carole COZE, MD, Contact, +33(0)491386821, [email protected]
Carole COZE, MD, Principal Investigator
Recruiting
MONTPELLIER CHU Hopital Arnaud De Villeneuve, Montpellier, 34295, France
Nicolas SIRVENT, MD, Contact, +33(0)467336519, [email protected]
Nicolas SIRVENT, MD, Principal Investigator
Recruiting
NANTES CHU Hopital Mere-Enfant, Nantes, 44093, France
LECULEE THEBAUD Estelle, MD, Contact, +33(0)240083610, [email protected]
LECULEE THEBAUD Estelle, MD, Principal Investigator
Recruiting
NICE CHU Hopital Archet 2, Nice, 06202, France
Gwenaëlle DUHIL DE BENAZE, MD, Contact, +33(0)492036064, [email protected]
Gwenaëlle DUHIL DE BENAZE, MD, Principal Investigator
Recruiting
Institut Curie, Paris, 75005, France
Livia LUMBROSO LE ROUIC, MD, Contact, +33(0)144324163, [email protected]
Isabelle AERTS, MD, Contact, +33(0)144324333, [email protected]
LIvia LUMBROSO LE ROUIC, MD, Principal Investigator
Recruiting
PARIS Fondation Ophtalmologique Adolphe de Rothschild, Paris, 75019, France
Raphaël BLANC, MD, Contact, +33(0)148036828, [email protected]
Raphaël BLANC, MD, Principal Investigator
Recruiting
Poitiers Chu, Poitiers, 86021, France
Frédéric MILLOT, MD, Contact, +33(0)549443078, [email protected]
Frédéric MILLOT, MD, Principal Investigator
Recruiting
Reims Chu, Reims, 51092, France
Claire PLUCHART, MD, Contact, +33(0)326787515, [email protected]
Claire PLUCHART, MD, Principal Investigator
Recruiting
Rennes Chu, Rennes, 35056, France
Chloé PUISEUX, MD, Contact, +33(0)299265917, [email protected]
Chloé PUISEUX, MD, Principal Investigator
Recruiting
Rouen Chu, Rouen, 76000, France
Cécile DUMESNIL DE MARICOURT, MD, Contact, +33(0)232888191, [email protected]
Cécile DUMESNIL DE MARICOURT, MD, Principal Investigator
Recruiting
Saint Etienne Chu, Saint-Etienne, 42055, France
Jean-Louis STEPHAN, MD, Contact, +33(0)478828608, [email protected]
Jean-Louis STEPHAN, MD, Principal Investigator
Recruiting
Strasbourg Chu, Strasbourg, 67098, France
Natacha ENTZ WERLE, MD, Contact, +33(0)388128396, [email protected]
Natacha ENTZ WERLE, MD, Principal Investigator
Recruiting
Toulouse Chu, Toulouse, 31026, France
Anne-Isabelle BERTOZZI-SALAMON, MD, Contact, +33(0)534558613, [email protected]
Anne-Isabelle BERTOZZI-SALAMON, MD, Principal Investigator
Recruiting
TOURS CHU Hopital Clocheville, Tours, 37044, France
Pascale BLOUIN, MD, Contact, +33(0)247474751, [email protected]
Pascale BLOUIN, MD, Principal Investigator
Recruiting
Nancy Chu, Vandœuvre-lès-Nancy, 54500, France
Ludovic MANSUY, MD, Contact, +33(0)383154734, [email protected]
Ludovic MANSUY, MD, Principal Investigator
Recruiting