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

Summary

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

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

Sponsors & Collaborators

• Institut Curie

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-18

Primary Completion

2031-03-01

Completion

2031-03-01

Countries

• France

Study Locations