Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)

PHASE2RecruitingINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

March 18, 2010

Primary Completion Date

March 1, 2031

Study Completion Date

March 1, 2031

Conditions
Retinoblastoma
Interventions
OTHER

Observation

no post operative chemotherapy

DRUG

Etoposide

100 mg/m²/d, IV (in the vein) from D1 to D5.

DRUG

Vincristine

1, 5 mg/m²/d, IV at D1.

RADIATION

Orbital irradiation

45 Grays (Standard or external beam radiotherapy).

DRUG

Carboplatin

160 mg/m²/d, IV from D1 to D5.

DRUG

Vincristine

1,5 mg/m²/d, IV at D22 and D26

DRUG

Cyclophosphamide

300 mg/m²/d, IV from D22 to D26.

DRUG

Carboplatin

560 mg/m²/d, IV at D1.

DRUG

Etoposide

100 mg/m²/d, IV from D1 to D5

DRUG

Carboplatin

160 mg/m²/d,IV from D1 to D5

DRUG

Thiotepa

15 mg, intrathecal Thiotepa injection at D1.

DRUG

Vincristine

1,5 mg/m²/d), IV at D22

DRUG

Cyclophosphamide

1000 mg/m²/d, IV from D22 à D24.

PROCEDURE

Cytapheresis

Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.

DRUG

Carboplatin

AUC : 7/d, IV from D-8 to D-6.

DRUG

Etoposide

250 mg/m²/d, IV from D -5 to D-3.

DRUG

Thiotepa

300 mg/m²/d, IV from D-5 to D-3.

PROCEDURE

Peripheral bood stem cell transplantation

at D0

Trial Locations (27)

13385

RECRUITING

Hopital D'Enfants La Timone, Marseille

14033

RECRUITING

CHU CAEN, Caen

21079

RECRUITING

Chu Bocage, Dijon

25030

RECRUITING

Hopital Jean Minioz, Besançon

29609

RECRUITING

Chu Morvan, Brest

31026

RECRUITING

Chu Toulouse, Toulouse

33076

RECRUITING

Chu R; Pellegrin, Bordeaux

34295

RECRUITING

Hopital Arnaud de Villeneuve, Montpellier

35056

RECRUITING

Chu de Rennes, Rennes

37044

RECRUITING

Chu Tours, Tours

38043

RECRUITING

Chu de Grenoble, Grenoble

44093

RECRUITING

Chu Nantes, Nantes

49033

RECRUITING

Chu Angers, Angers

51100

RECRUITING

Chur de Reims, Reims

54500

RECRUITING

Chu Nancy, Vandœuvre-lès-Nancy

59020

RECRUITING

Centre Oscar Lambret, Lille

63003

RECRUITING

Chu Estaing, Clermont-Ferrand

67098

RECRUITING

Hoptial Hautepierre, Strasbourg

69373

RECRUITING

Centre Leon Berard, Lyon

75005

RECRUITING

Institut Curie, Paris

76031

RECRUITING

Chu de Rouen, Rouen

80054

RECRUITING

Hopital Nord Chu Amiens, Amiens

86021

RECRUITING

Chu de Poitiers, Poitiers

87042

RECRUITING

Chu Limoges, Limoges

97405

RECRUITING

Chr Felix Guyon, Saint-Denis

420555

RECRUITING

Chu Saint Etienne, Saint-Etienne

06202

RECRUITING

Chu de Nice, Nice

All Listed Sponsors
lead

Institut Curie

OTHER