Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
Condition(s) studied
Investigational drug(s) / intervention(s)
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)
Study 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.
Eligibility
Primary outcome measure(s)
- Study 1: Rate of eye preservation — 24 months after randomization
Rate of eye preservation in the 2 treatments' arms - Visual function — when patient is 6 years old and at least 24 months of follow-up after study inclusion
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
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| La Reunion - Chr Felix Guyon | Saint-Denis | La Réunion | Recruiting |
| Amiens Chu | Amiens | France | Recruiting |
| Angers Chu | Angers | France | Recruiting |
| BESANCON CHU Hopital Jean Minjoz | Besançon | France | Recruiting |
| Bordeaux Chu | Bordeaux | France | Recruiting |
| BREST CHRU Hopital Morvan | Brest | France | Recruiting |
| CAEN CHU | Caen | France | Recruiting |
| CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP) | Clermont-Ferrand | France | Recruiting |
| DIJON CHU Hopital François Mitterand | Dijon | France | Recruiting |
| Grenoble Chu | Grenoble | France | Recruiting |
| LILLE Centre Oscar Lambret | Lille | France | Recruiting |
| Limoges Chu | Limoges | France | Recruiting |
| LYON Centre Léon Bérard | Lyon | France | Recruiting |
| Marseille Chu | Marseille | France | Recruiting |
| MONTPELLIER CHU Hopital Arnaud De Villeneuve | Montpellier | France | Recruiting |
| NANTES CHU Hopital Mere-Enfant | Nantes | France | Recruiting |
| NICE CHU Hopital Archet 2 | Nice | France | Recruiting |
| Institut Curie | Paris | France | Recruiting |
| PARIS Fondation Ophtalmologique Adolphe de Rothschild | Paris | France | Recruiting |
| Poitiers Chu | Poitiers | France | Recruiting |
| Reims Chu | Reims | France | Recruiting |
| Rennes Chu | Rennes | France | Recruiting |
| Rouen Chu | Rouen | France | Recruiting |
| Saint Etienne Chu | Saint-Etienne | France | Recruiting |
| Strasbourg Chu | Strasbourg | France | Recruiting |
| Toulouse Chu | Toulouse | France | Recruiting |
| TOURS CHU Hopital Clocheville | Tours | France | Recruiting |
| Nancy Chu | Vandœuvre-lès-Nancy | France | Recruiting |
More Institut Curie trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04681417 on ClinicalTrials.gov ↗ ← All trials in France