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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Systemic treatment : Intravenous injections, 2 cycles (21 days)
intraarterial injections, 3 to 6 cycles (1 month)
Systemic treatment : Intravenous injections, 6 cycles (21 days)
Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1
Institut Curie
Paris, France
Rate of enucleation and external beam irradiation
Time frame: From first day of treatment to 18 months after the end of treatments
Number of relapses diagnosticated by fundus examination under general anesthesia until the age of 4 years, and without general anesthesia for older patients
Number of fundus examination positives without clinical symptoms and number of patients treated after fundus examination-related treatment with a controlled disease.
Time frame: 5 years
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
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.
Time frame: 5 years
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
Rate of patient with a progression disease and/or presenting a medium/long term adverse event(s) or a second cancer.
Time frame: 5 years
Response to intravitreal chemotherapy by Melphalan
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.
Time frame: 18 months
Radiation doses received during intraarterial procedures
Time of scopies during ophthalmic arterial catheterism, doses delivered by the machine, doses received on skin.
Time frame: 18 months
Number of patients presenting a long term second tumour
Time frame: until 20 years old
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