Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
NCT ID: NCT04681417
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
225 participants
INTERVENTIONAL
2021-03-25
2036-01-20
Brief Summary
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* 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.
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Detailed Description
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* 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study 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)
Study 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)
Interventions
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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.
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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).
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.
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.
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.
6 Months
6 Years
ALL
No
Sponsors
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Fondation Rothschild Paris
OTHER
Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Livia LUMBROSO LE ROUIC, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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La Reunion - Chr Felix Guyon
Saint-Denis, La Réunion, France
Amiens Chu
Amiens, , France
Angers Chu
Angers, , France
BESANCON CHU Hopital Jean Minjoz
Besançon, , France
Bordeaux Chu
Bordeaux, , France
BREST CHRU Hopital Morvan
Brest, , France
CAEN CHU
Caen, , France
CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP)
Clermont-Ferrand, , France
DIJON CHU Hopital François Mitterand
Dijon, , France
Grenoble Chu
Grenoble, , France
LILLE Centre Oscar Lambret
Lille, , France
Limoges Chu
Limoges, , France
LYON Centre Léon Bérard
Lyon, , France
Marseille Chu
Marseille, , France
MONTPELLIER CHU Hopital Arnaud De Villeneuve
Montpellier, , France
NANTES CHU Hopital Mere-Enfant
Nantes, , France
NICE CHU Hopital Archet 2
Nice, , France
Institut Curie
Paris, , France
PARIS Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
Poitiers Chu
Poitiers, , France
Reims Chu
Reims, , France
Rennes Chu
Rennes, , France
Rouen Chu
Rouen, , France
Saint Etienne Chu
Saint-Etienne, , France
Strasbourg Chu
Strasbourg, , France
Toulouse Chu
Toulouse, , France
TOURS CHU Hopital Clocheville
Tours, , France
Nancy Chu
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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IC 2019-05
Identifier Type: -
Identifier Source: org_study_id
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