Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome (RETINO2018)
Retinoblastoma
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring Pediatric, Ocular conservative treatment in retinoblastoma
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- La Reunion - Chr Felix GuyonRecruiting
- Amiens ChuRecruiting
- Angers ChuRecruiting
- BESANCON CHU Hopital Jean MinjozRecruiting
- Bordeaux ChuRecruiting
- BREST CHRU Hopital MorvanRecruiting
- CAEN CHURecruiting
- CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP)Recruiting
- DIJON CHU Hopital François MitterandRecruiting
- Grenoble ChuRecruiting
- LILLE Centre Oscar LambretRecruiting
- Limoges ChuRecruiting
- LYON Centre Léon BérardRecruiting
- Marseille ChuRecruiting
- MONTPELLIER CHU Hopital Arnaud De VilleneuveRecruiting
- NANTES CHU Hopital Mere-EnfantRecruiting
- NICE CHU Hopital Archet 2Recruiting
- Institut CurieRecruiting
- PARIS Fondation Ophtalmologique Adolphe de RothschildRecruiting
- Poitiers ChuRecruiting
- Reims ChuRecruiting
- Rennes ChuRecruiting
- Rouen ChuRecruiting
- Saint Etienne ChuRecruiting
- Strasbourg ChuRecruiting
- Toulouse ChuRecruiting
- TOURS CHU Hopital ClochevilleRecruiting
- Nancy ChuRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Study 1: Melphalan or Melphalan + Topotecan
Study 2: Etoposide, carboplatin and vincristine
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.
Neoadjuvant chemotherapy involves 2 to 6 cycles of combined etoposide, carboplatin and vincristine in association with ophthalmologic treatments.