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

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 or local ophthalmological treatment without IV chemotherapy.

Conditions

• Retinoblastoma

Interventions

DRUG

Melphalan or Melphalan + Topotecan

IAC: 2-6 cycles every 1 month (number based on the local tumor evolution), performed using radio-guided catheterization and delivery at the ostium of the ophthalmic artery, in neuroradiology operating room, and under General Anesthesia (GA). IAC will be administered at the Fondation Rothschild Hospital in collaboration with the Interventional Neuroradiology team.

DRUG

etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy

2 to 6 cycles of combined etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy : thermotherapy and/or cryotherapy and/or iodine-125 plaques and/or intravitreal chemotherapy injections

DRUG

Carboplatin administered on Day 1

Chemothermotherapy : Intravenous injection by carboplatin

DEVICE

Thermotherapy (local treatment)

Thermotherapy after carboplatin administered on Day 1

DEVICE

Cryotherapy (local treatment)

Cryotherapy (local treatment)

DEVICE

Iodine-125 plaques (local treatment)

Iodine-125 plaques (local treatment)

DRUG

Intravitreal Melphalan chemotherapy injections (local treatment)

Intravitreal Melphalan chemotherapy injections (local treatment)

Sponsors & Collaborators

• Institut Curie

  lead OTHER

• Fondation Rothschild Paris

  collaborator OTHER

Principal Investigators

• Livia LUMBROSO LE ROUIC, MD · Institut Curie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-25

Primary Completion

2035-01-20

Completion

2036-01-20

Countries

• France

Study Locations