Conservative Treatments of Retinoblastoma

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Brief Title

Conservative Treatments of Retinoblastoma

Official Title

Conservative Treatments of Retinoblastoma

Brief Summary

      Conservative treatments of retinoblastoma (RETINO 2011)

        1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction
           (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8

        2. -Multicentric non randomised, phase II study for the patients with bilateral very
           asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups
           B/C/D according to the age and vitreous seeding

        3. - Multicentric non randomised, phase II study for the patients treated by 6 cycles of
           three drugs regimen and local treatments for bilateral group D eyes or on the only eye.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of enucleation and external beam irradiation

Secondary Outcome

 Number of relapses diagnosticated by fundus examination under general anesthesia until the age of 4 years, and without general anesthesia for older patients

Condition

Retinoblastoma

Intervention

VP16, carboplatin

Study Arms / Comparison Groups

 (IV)Intravenous chemotherapy, laser diode
Description:  Group 1 - Multicentric non randomised, phase II study for patients with retinoblastoma (unilateral group A,B according to age, group C according to the age and the vitreous seeding or bilateral groups A,B and C excluding the bilateral groups D or patients with bilateral macular threat).
Treatment by chemoreduction (VP16, carboplatin) followed by Carboplatin + laser day 1 (chemothermotherapy) without laser treatment at day 8 (decreasing laser sessions) combined to local treatments from third course (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan).

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

133

Start Date

February 2012

Completion Date

February 2027

Primary Completion Date

August 2024

Eligibility Criteria

        Inclusion Criteria:

        Study 1 inclusion criteria:

          -  Patients affected by unilateral retinoblastoma groups A, B (according to the age),
             group C (according to the age and vitreous seeding),or bilateral retinoblastoma groups
             A, B, C (excluding the eyes with macular threat and bilateral group D eyes or on the
             only remaining eye) amenable to a conservative treatment (at least on one eye in
             bilateral disease) but needing initial chemotherapy because of the location, the size
             of the lesion (more than 4 mm of diameter), a vision threat or risks of intravitreal
             relapse making those patients not amenable to chemothermotherapy first line.

          -  Patients less than six months of age with unilateral retinoblastoma groups B, C, D, or
             bilateral very asymmetric with one eye group D and the other amenable to local
             treatments without chemotherapy.

          -  Children from 0 to 6 years old.

        Study 2 inclusion criteria:

          -  Patients affected by unilateral or bilateral retinoblastoma group B (according to the
             age), group C (according to the age and vitreous seeding), or group D.

          -  Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that
             can be treated by intraarterial chemotherapy by Melphalan and the other amenable to
             local treatments without chemotherapy.

          -  Children from 6 months to 6 years old.

        Study 3 inclusion criteria:

          -  Children affected of bilateral group D retinoblastoma or on the only eye amenable to
             conservative treatment.

          -  Children from 0 to 6 years old.

        Common inclusion criteria:

          -  Patients not previously treated by chemotherapy or radiotherapy for this tumour or
             another cancer.

          -  No contra-indications to the study treatments

          -  Possible long term follow-up.

          -  Written informed consent of the parents or the legal representative.

          -  Patients having social security cover.

        Exclusion Criteria:

        Study 1 exclusion criteria:

          -  Patients for whom a local treatment is possible without initial chemotherapy (tumour
             smaller than 4 mm and located far from optic nerve head or macula).

          -  Patients with an unilateral group D with massive tumour or group E eyes needing
             enucleation first line or after initial chemotherapy (in case of buphthalmia or
             suspected optic nerve invasion or extrascleral extension).

          -  Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that
             can be treated by intraarterial chemotherapy by Melphalan and the other amenable to
             local treatments without chemotherapy.

          -  Patients with bilateral retinoblastoma and bilateral group D eyes or on the only
             remaining eye or presenting a bilateral macular threat requiring conservative
             treatment by a 6 cycles, three drugs regimen.

        Study 2 exclusion criteria:

          -  Patients with a unilateral group D (extensive) or B or C but covering the optic nerve
             head or group E eyes for which enucleation is warranted first line or after
             chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral
             extension).

          -  Patients with unilateral group D eye with tumour volume of more than 50% of eye
             volume, for whom a massive choroidal invasion could be associated (on clinical or
             imaging criteria) and for which enucleation is warranted.

        Study 3 exclusion criteria:

          -  Patients for whom a local treatment is possible without chemoreduction (tumour smaller
             than 4 mm, distant from macula and from optic nerve head).

          -  Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that
             can be treated by intraarterial chemotherapy by Melphalan and the other amenable to
             local treatments without chemotherapy.

          -  Patients with bilateral retinoblastoma without macular threat or groups A, B, C than
             can be treated with chemoreduction by VP16 and Carboplatin then chemothermotherapy
             without laser at day 8.

        Common exclusion criteria:

          -  Patients older than 6 years old.

          -  Patients with extraocular retinoblastoma.

          -  Patients with a disease being a contra-indication to chemotherapy.

          -  Patients anteriorly treated by chemotherapy.

          -  Patients anteriorly treated by external beam irradiation.

          -  Patients anteriorly treated for another cancer.

          -  Follow-up not possible due to geographic distance from the center or for social or
             psychological reasons.

          -  Parents not having accepted the therapeutic strategy after explanations by the
             investigator.

          -  Contra-indication to the use of one of the drugs used in the study.
      

Gender

All

Ages

N/A - 6 Years

Accepts Healthy Volunteers

No

Contacts

Isabelle Aerts, MD, 33(0)1 44 32 46 02, 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02866136

Organization ID

IC 2011-05


Responsible Party

Sponsor

Study Sponsor

Institut Curie

Collaborators

 Fondation Rothschild Paris

Study Sponsor

Isabelle Aerts, MD, Study Director, Institut Curie - Paris - France


Verification Date

August 2020