Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6-6
SponsorInstitut Curie

About this trial

This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients:

* Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. * Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.

Eligibility criteria

Qualifiers

Newly diagnosed retinoblastoma (RB).

Retinoblastoma with at least one eye eligible for conservative management.

Patients likely to be compliant with the study requirements and visits, including late follow-up.

Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.

Disqualifiers

Extra-ocular extension of the disease, or

Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye.

Patient older than 6 years of age.

Patients with another associated disease contra indicating systemic chemotherapy.

Trial design

Treatments tested in this trial

  • Melphalan or Melphalan + Topotecan
  • etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy
  • Carboplatin administered on Day 1
  • Thermotherapy (local treatment)
  • Cryotherapy (local treatment)
  • Iodine-125 plaques (local treatment)
  • Intravitreal Melphalan chemotherapy injections (local treatment)

Treatment groups

225 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Institut Curie

Lead sponsor

Fondation Rothschild Paris

Collaborator