Conservative Treatments of Retinoblastoma

• Status: Recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Curie
• Collaborator: Fondation Rothschild Paris
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Melphalan; Vincristine

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.