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

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Brief Title

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

Official Title

Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018

Brief 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.
    

Detailed 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).
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Study 1: Rate of eye preservation

Secondary Outcome

 Ocular toxicity

Condition

Retinoblastoma

Intervention

Melphalan or Melphalan + Topotecan

Study Arms / Comparison Groups

 Study 1: Melphalan or Melphalan + Topotecan
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

225

Start Date

February 11, 2021

Completion Date

January 20, 2036

Primary Completion Date

January 20, 2035

Eligibility Criteria

        Inclusion Criteria:

        Overall study inclusion criteria:

          1. Newly diagnosed retinoblastoma (RB).

          2. Retinoblastoma with at least one eye eligible for conservative management.

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

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

          5. Patients with no contraindication to the proposed treatments.

          6. Informed consent signed by parents or legal representative.

          7. French Social Security System coverage.

        Study 1 inclusion criteria:

        8.1. Children aged from 6 months to 6 years. 9. Retinoblastoma in at least one eye, deemed
        manageable with IAC in one side and without IV chemotherapy:

          1. Unilateral Retinoblastoma classified as group B, C (if vitreous seeds < 3 mm), D or E
             with no invasion of the anterior segment, and without massive tumor of more than 2/3
             of the eye, eligible for conservative management, or

          2. Bilateral Retinoblastoma but with very unbalanced lesions between the two eyes: one
             eye group D or E without invasion of the anterior segment or massive tumor of more
             than 2/3 of the eye, eligible for IAC, and the other eye eligible for local treatment
             only (without IAC).

        Study 2 inclusion criteria:

        8.2. Retinoblastoma eligible for conservative management although not manageable with IAC:

          1. Unilateral Retinoblastoma in children below 6 months of age, classified as Group A, B,
             C or D, with or without vitreous seeding, compatible with conservative management, or

          2. Bilateral Retinoblastoma classified as group A, B, C D, or E without invasion of the
             anterior segment, and/or massive tumors of more than 2/3 of the eye and eligible for
             conservative management.

        Exclusion Criteria:

        Overall study non-inclusion criteria:

          1. RB not eligible for conservative management :

               1. Extra-ocular extension of the disease, or

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

          2. Patient older than 6 years of age.

          3. Patients with another associated disease contra indicating systemic chemotherapy.

          4. Previously treated retinoblastoma by chemotherapy.

          5. Patients already treated for another malignant disease.

          6. Patient with any psychological, familial, sociological or geographical condition
             potentially hampering compliance with the study protocol and follow-up schedule.

          7. Patients whose parents have not accepted the treatment regimen after explanation of
             it.

          8. Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics)
             of the study drugs.

          9. Inclusion in another experimental anti-cancer drug therapy.

             Study 1 non-inclusion criteria:

         10. Any contraindication or concomitant disease that would preclude the Study 1 treatment
             procedure and could delay treatment.

        These patients should be eligible for Study 2.
      

Gender

All

Ages

6 Months - 6 Years

Accepts Healthy Volunteers

No

Contacts

, +33(0)144324163, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04681417

Organization ID

IC 2019-05


Responsible Party

Sponsor

Study Sponsor

Institut Curie

Collaborators

 Fondation Rothschild Paris

Study Sponsor

, , 


Verification Date

December 2020