Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of the International Retinoblastoma Staging Working Group. * Low risk group : * No optic nerve involvement. * Intra and prelaminar involvement * No choroidal involvement. * Minimal superficial choroidal involvement . * Intermediate risk group, 2 sub groups : * Sub group 1 : * Retrolaminar involvement without Invasion of surgical margin associated or not to massive choroidal involvement * Anterior segment involvement. * Intrascleral involvement. * Sub Group 2 : * Isolated massive choroidal involvement. * High risk group : * Invasion of the surgical margin of the optic nerve * and/or microscopic extrascleral involvement * Optic nerve meningeal sheat involvement .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
no post operative chemotherapy
100 mg/m²/d, IV (in the vein) from D1 to D5.
1, 5 mg/m²/d, IV at D1.
Chr Felix Guyon
Saint-Denis, La Réunion, France
Hopital Nord Chu Amiens
Rate of extra ocular relapses
Time frame: 5 years
Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.
Number of participants with treatment-related Adverse Events as assessed by CTCAE v3.0.
Time frame: 5 years
Number of patient with secondary bilateralisation
Time frame: 5 years
Evaluate the different histopathological risk factors frequency
Number of patient in each histopathological risk group
Time frame: 5 years
To determine tumors genomic
Tumor genomic characterization in order to provide some new prognosis factors and better understanding of tumorigenesis by using of NGS (Next Generation Sequencing) techniques
Time frame: at the inclusion
Evaluate sensitivity of MRI in detecting extra ocular extension
Number of extra ocular extension detected by MRI
Time frame: At the inclusion
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45 Grays (Standard or external beam radiotherapy).
160 mg/m²/d, IV from D1 to D5.
1,5 mg/m²/d, IV at D22 and D26
300 mg/m²/d, IV from D22 to D26.
560 mg/m²/d, IV at D1.
100 mg/m²/d, IV from D1 to D5
160 mg/m²/d,IV from D1 to D5
15 mg, intrathecal Thiotepa injection at D1.
1,5 mg/m²/d), IV at D22
1000 mg/m²/d, IV from D22 à D24.
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.
AUC : 7/d, IV from D-8 to D-6.
250 mg/m²/d, IV from D -5 to D-3.
300 mg/m²/d, IV from D-5 to D-3.
at D0
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
...and 17 more locations