Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)
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|ClinicalTrials.gov Identifier: NCT02870907|
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Retinoblastoma||Other: Observation Drug: Etoposide Drug: Vincristine Radiation: Orbital irradiation Drug: Carboplatin Drug: Cyclophosphamide Drug: Thiotepa Procedure: Cytapheresis Procedure: Peripheral bood stem cell transplantation||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2029|
|Estimated Study Completion Date :||September 2029|
|Experimental: Low risk group||
no post operative chemotherapy
Experimental: Intermediate risk sub group 1
2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
100 mg/m²/d, IV (in the vein) from D1 to D5.
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.
Experimental: Intermediate risk sub group 2
2 courses of Vincristin and Carboplatin
1, 5 mg/m²/d, IV at D1.
560 mg/m²/d, IV at D1.
Experimental: High risk group
Radiation: Orbital irradiation
45 Grays (Standard or external beam radiotherapy).
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.
Procedure: Peripheral bood stem cell transplantation
- Rate of extra ocular relapses [ Time Frame: 5 years ]
- Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary. [ Time Frame: 5 years ]Number of participants with treatment-related Adverse Events as assessed by CTCAE v3.0.
- Number of patient with secondary bilateralisation [ Time Frame: 5 years ]
- Evaluate the different histopathological risk factors frequency [ Time Frame: 5 years ]Number of patient in each histopathological risk group
- To determine tumors genomic [ Time Frame: at the inclusion ]Tumor genomic characterization in order to provide some new prognosis factors and better understanding of tumorigenesis by using of NGS (Next Generation Sequencing) techniques
- Evaluate sensitivity of MRI in detecting extra ocular extension [ Time Frame: At the inclusion ]Number of extra ocular extension detected by MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870907
|Contact: Isabelle AERTS, MDfirstname.lastname@example.org|