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

ConditionRetinoblastoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Melphalan or Melphalan + Topotecan

    Drug

    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.

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

    Drug

    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

  • Carboplatin administered on Day 1

    Drug

    Chemothermotherapy : Intravenous injection by carboplatin

  • Thermotherapy (local treatment)

    Device

    Thermotherapy after carboplatin administered on Day 1

  • Cryotherapy (local treatment)

    Device

    Cryotherapy (local treatment)

  • Iodine-125 plaques (local treatment)

    Device

    Iodine-125 plaques (local treatment)

  • Intravitreal Melphalan chemotherapy injections (local treatment)

    Drug

    Intravitreal Melphalan chemotherapy injections (local treatment)

Treatment groups

225 Participants
are divided into 2 treatment groups
Group A: Study 1: Melphalan or Melphalan + TopotecanExperimental treatment 5 interventions
Group B: Study 2: Etoposide, carboplatin and vincristineOther 6 interventions

Trial outcomes

Primary outcomes

1

Study 1: Rate of eye preservation

Rate of eye preservation in the 2 treatments' arms

Time frame
24 months after randomization
2

Visual function

Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension

Time frame
when patient is 6 years old and at least 24 months of follow-up after study inclusion

Secondary outcomes

1

Ocular toxicity

Percentage of patients with at least one grade-3 or -4 toxicity (CTCAE v. 5.0)

Time frame
Up to 24 months after inclusion in the study
2

Systemic toxicity

Rate of specific grade 3-4 toxicity (CTCAE v. 5.0)

Time frame
Up to 24 months after inclusion in the study
3

Relapse

Percentage of patients with relapse within 24 months after inclusion, broken down into: Local relapse, Extra-ocular relapse

Time frame
within 24 months after inclusion
4

Second malignant tumor

Percentage of patients with second malignant tumor within 24 months after study inclusion

Time frame
24 months after study inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Curie

Lead sponsor

Fondation Rothschild Paris

Collaborator

Source ClinicalTrials.gov
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