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ACTIVE NOT RECRUITING
NCT02870907
PHASE2

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

Sponsor: Institut Curie

View on ClinicalTrials.gov

Summary

Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

Official title: Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

Key Details

Gender

All

Age Range

2 Months - 10 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2010-03-18

Completion Date

2031-03-01

Last Updated

2026-01-07

Healthy Volunteers

No

Conditions

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

Locations (27)

Chr Felix Guyon

Saint-Denis, La Réunion, France

Hopital Nord Chu Amiens

Amiens, France

Chu Angers

Angers, France

Hopital Jean Minioz

Besançon, France

Chu R; Pellegrin

Bordeaux, France

Chu Morvan

Brest, France

CHU CAEN

Caen, France

Chu Estaing

Clermont-Ferrand, France

Chu Bocage

Dijon, France

Chu de Grenoble

Grenoble, France

Centre Oscar Lambret

Lille, France

Chu Limoges

Limoges, France

Centre Leon Berard

Lyon, France

Hopital D'Enfants La Timone

Marseille, France

Hopital Arnaud de Villeneuve

Montpellier, France

Chu Nantes

Nantes, France

Chu de Nice

Nice, France

Institut Curie

Paris, France

Chu de Poitiers

Poitiers, France

Chur de Reims

Reims, France

Chu de Rennes

Rennes, France

Chu de Rouen

Rouen, France

Chu Saint Etienne

Saint-Etienne, France

Hoptial Hautepierre

Strasbourg, France

Chu Toulouse

Toulouse, France

Chu Tours

Tours, France

Chu Nancy

Vandœuvre-lès-Nancy, France