NCT02870907

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

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 2 Months – 10 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 .

Conditions

• Retinoblastoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-03-18
• Primary completion: 2031-03-01
• Completion: 2031-03-01
• First posted: 2016-08-17
• Last updated: 2026-01-07

Locations

27 sites across 1 country: France