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.

  • 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 .

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