Clinical Trial: Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated
Brief Summary: Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
Detailed Summary:
Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
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Low risk group :
- No optic nerve involvement.
- Intra and prelaminar involvement
- No choroidal involvement.
- Minimal superficial choroidal involvement .
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Intermediate risk group, 2 sub groups :
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Sub group 1 :
- Retrolaminar involvement without Invasion of surgical margin associated or not to massive choroidal involvement
- Anterior segment involvement.
- Intrascleral involvement.
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Sub Group 2 :
- Isolated massive choroidal involvement.
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High risk group :
- Invasion of the surgical margin of the optic nerve
- and/or microscopic extrascleral involvement
- Optic nerve meningeal sheat involvement .
Sponsor: Institut Curie
Current Primary Outcome: Rate of extra ocular relapses [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Institut Curie
Dates:
Date Received: August 9, 2016
Date Started: March 2010
Date Completion: September 2026
Last Updated: August 12, 2016
Last Verified: July 2016