Clinical Trial: Conservative Treatments of Retinoblastoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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.

Detailed Summary:
Sponsor: Institut Curie

Current Primary Outcome: Rate of enucleation and external beam irradiation [ Time Frame: From first day of treatment to 18 months after the end of treatments ]

Original Primary Outcome: Same as current

Current 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 [ Time Frame: 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 [ Time Frame: 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.
  • 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 [ Time Frame: 5 years ]
    Rate of patient with a progression disease and/or presenting a medium/long term adverse event(s) or a second cancer.
  • Response to intravitreal chemotherapy by Melphalan [ Time Frame: 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 [ Time Frame: 18 months ]
    Time of scopies during ophthalmic arterial catheterism, doses delivered by the machine, doses received on skin.
  • Number of patients presenting a long term second tumour [ Time Frame: until 20 years old ]


Original 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 [ Time Frame: 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 [ Time Frame: 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 Independant data monitoring Committee), for each arm of the study and for the whole study.
  • 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 [ Time Frame: 5 years ]
    Rate of patient with a progression disease and/or presenting a medium/long term adverse event(s) or a second cancer.
  • Response to intravitreal chemotherapy by Melphalan [ Time Frame: 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 [ Time Frame: 18 months ]
    Time of scopie during ophtalmic arterial catheterism, doses deliverated by the machine, doses received on skin.
  • Number of patients presenting a long term second tumour [ Time Frame: until 20 years old ]


Information By: Institut Curie

Dates:
Date Received: July 27, 2016
Date Started: February 2012
Date Completion: February 2027
Last Updated: October 3, 2016
Last Verified: July 2016