Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

March 25, 2021

Primary Completion Date

January 20, 2035

Study Completion Date

January 20, 2036

Conditions
Retinoblastoma
Interventions
DRUG

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.

DRUG

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

DRUG

Carboplatin administered on Day 1

Chemothermotherapy : Intravenous injection by carboplatin

DEVICE

Thermotherapy (local treatment)

Thermotherapy after carboplatin administered on Day 1

DEVICE

Cryotherapy (local treatment)

Cryotherapy (local treatment)

DEVICE

Iodine-125 plaques (local treatment)

Iodine-125 plaques (local treatment)

DRUG

Intravitreal Melphalan chemotherapy injections (local treatment)

Intravitreal Melphalan chemotherapy injections (local treatment)

Trial Locations (28)

13385

RECRUITING

Marseille Chu, Marseille

14033

RECRUITING

CAEN CHU, Caen

21079

RECRUITING

DIJON CHU Hopital François Mitterand, Dijon

25030

RECRUITING

BESANCON CHU Hopital Jean Minjoz, Besançon

29609

RECRUITING

BREST CHRU Hopital Morvan, Brest

31026

RECRUITING

Toulouse Chu, Toulouse

33076

RECRUITING

Bordeaux Chu, Bordeaux

34295

RECRUITING

MONTPELLIER CHU Hopital Arnaud De Villeneuve, Montpellier

35056

RECRUITING

Rennes Chu, Rennes

37044

RECRUITING

TOURS CHU Hopital Clocheville, Tours

38045

RECRUITING

Grenoble Chu, Grenoble

42055

RECRUITING

Saint Etienne Chu, Saint-Etienne

44093

RECRUITING

NANTES CHU Hopital Mere-Enfant, Nantes

49033

RECRUITING

Angers Chu, Angers

51092

RECRUITING

Reims Chu, Reims

54500

RECRUITING

Nancy Chu, Vandœuvre-lès-Nancy

59037

RECRUITING

LILLE Centre Oscar Lambret, Lille

63003

RECRUITING

CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP), Clermont-Ferrand

67098

RECRUITING

Strasbourg Chu, Strasbourg

69373

RECRUITING

LYON Centre Léon Bérard, Lyon

75005

RECRUITING

Institut Curie, Paris

75019

RECRUITING

PARIS Fondation Ophtalmologique Adolphe de Rothschild, Paris

76000

RECRUITING

Rouen Chu, Rouen

80054

RECRUITING

Amiens Chu, Amiens

86021

RECRUITING

Poitiers Chu, Poitiers

87042

RECRUITING

Limoges Chu, Limoges

97405

RECRUITING

La Reunion - Chr Felix Guyon, Saint-Denis

06202

RECRUITING

NICE CHU Hopital Archet 2, Nice

All Listed Sponsors
collaborator

Fondation Rothschild Paris

OTHER

lead

Institut Curie

OTHER