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

  • STATUS
    Recruiting
  • End date
    Jan 20, 2036
  • participants needed
    225
  • sponsor
    Institut Curie
Updated on 13 April 2021

Summary

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 treatments.

Description

Primary objective of the studies:

  • Study 1: To evaluate the efficacy of IAC in term of local control of the disease in patients eligible for IAC (randomized phase II study);
  • Study 2: To assess the visual function, based on World Health Organization (WHO) criteria, in patients eligible for other conservative treatments (IV chemotherapy in association with local ophthalmologic treatments; this is a minimally invasive interventional study).

Details
Condition Retinoblastoma
Treatment Melphalan or Melphalan + Topotecan, etoposide, carboplatin and vincristine, Carboplatin administered on Day 1, Thermotherapy (local treatment), Cryotherapy (local treatment), Iodine-125 plaques (local treatment), Intravitreal Melphalan chemotherapy injections (local treatment)
Clinical Study IdentifierNCT04681417
SponsorInstitut Curie
Last Modified on13 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

RB not eligible for conservative management
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
Previously treated retinoblastoma by chemotherapy
Patients already treated for another malignant disease
Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Patients whose parents have not accepted the treatment regimen after explanation of it
Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs
Inclusion in another experimental anti-cancer drug therapy
Study 1 non-inclusion criteria
\. Any contraindication or concomitant disease that would preclude the Study
treatment procedure and could delay treatment
These patients should be eligible for Study 2
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