Children, Retinal Neoplasm, Retinoblastoma
Conditions
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.
Interventions
DRUGVP16, carboplatin
Systemic treatment : Intravenous injections, 2 cycles (21 days)
DRUGMelphalan
intraarterial injections, 3 to 6 cycles (1 month)
DRUGVP16, carboplatin, vincristin
Systemic treatment : Intravenous injections, 6 cycles (21 days)
DRUGCarboplatin + laser day 1 (chemothermotherapy)
Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1
DEVICELaser (local treatment)
DEVICEcryoapplication (local treatment)
RADIATIONI125 radioactive plaques (local treatment)
DRUGintravitreal Melphalan (local treatment)
Sponsors
Fondation Rothschild Paris
Institut Curie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of enucleation and external beam irradiation | From first day of treatment to 18 months after the end of treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of relapses diagnosticated by fundus examination under general anesthesia until the age of 4 years, and without general anesthesia for older patients | 5 years | Number of fundus examination positives without clinical symptoms and number of patients treated after fundus examination-related treatment with a controlled disease. |
| Prospective evaluation of the systemic, ocular and general sides effects (short term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan | 5 years | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 and types of adverse events occuring in order to reassess the benefice-risk scale (by Independent Data Monitoring Committee), for each arm of the study and for the whole study. |
| Number of patients presenting a long term second tumour | until 20 years old | — |
| Response to intravitreal chemotherapy by Melphalan | 18 months | Number of patients with uncontrolled disease (progression) and/or presenting Adverse Event(s) as assessed by CTCAE v4.0, related to intravitreal chemotherapy by Melphalan. |
| Radiation doses received during intraarterial procedures | 18 months | Time of scopies during ophthalmic arterial catheterism, doses delivered by the machine, doses received on skin. |
| Prospective evaluation of the systemic, ocular and general sides effects (medium and long term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan | 5 years | Rate of patient with a progression disease and/or presenting a medium/long term adverse event(s) or a second cancer. |
Countries
France
Outcome results
None listed