DIAGNOSTIC AND THERAPEUTIC STUDY FOR NEWLY DIAGNOSED RETINOBLASTOMA PATIENTS RTB AIEOP 012

DIAGNOSTIC AND THERAPEUTIC STUDY FOR NEWLY DIAGNOSED RETINOBLASTOMA PATIENTS RTB AIEOP 012 - RTB AIEOP 012

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006109-85-IT

Enrollment

120

Registered

2012-03-07

Start date

2012-02-14

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed retinoblastoma patients MedDRA version: 14.1 Level: PT Classification code 10038916 Term: Retinoblastoma System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: CARBOPLATIN CAS Number: 41575-94-4 Current Sponsor code: Carboplatino Other descriptive name: NA Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Concomitant radiotherapy or chemotherapy or immunoomodulation -pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to improve the the ocular Event Free Survival at 1 year since diagnosis preseving the Overall Survival over 95% at 3 yeras modulating the intensity of the treatment according to intra ed extra ocular extension of disease.;Secondary Objective: Secondary Objectives are -a prospective validation of the Internationa Retinoblastoma Staging Sistem and of Classification System for Intraoculr Retinoblastoma. -to evaluete the relationship between the response after two courses and EFS at 12 months. -to evaluate the visual function in patients treated with aconservative strategy -to evaluate the acute and long-term toxicity, mainly the ototoxicity, in patients treated with a conservative approach. - to identify early clinical factors associated with a conservative approach failure. -to create a retinoblastoma tumor biobank;Primary end point(s): Ocular Event Free Survival at 12 months from diagnosis;Timepoint(s) of evaluation of this end point: The ocular EFS at 12 months will be calculated every 6 months until 12 months from the date of inclusion of the last patients.	—

Measure

Time frame

Main Objective: The main objective is to improve the the ocular Event Free Survival at 1 year since diagnosis preseving the Overall Survival over 95% at 3 yeras modulating the intensity of the treatment according to intra ed extra ocular extension of disease.;Secondary Objective: Secondary Objectives are -a prospective validation of the Internationa Retinoblastoma Staging Sistem and of Classification System for Intraoculr Retinoblastoma. -to evaluete the relationship between the response after two courses and EFS at 12 months. -to evaluate the visual function in patients treated with aconservative strategy -to evaluate the acute and long-term toxicity, mainly the ototoxicity, in patients treated with a conservative approach. - to identify early clinical factors associated with a conservative approach failure. -to create a retinoblastoma tumor biobank;Primary end point(s): Ocular Event Free Survival at 12 months from diagnosis;Timepoint(s) of evaluation of this end point: The ocular EFS at 12 months will be calculated every 6 months until 12 months from the date of inclusion of the last patients.

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Secondary

Measure	Time frame
Secondary end point(s): -concordanza tra la stadiazione IRSS e CSIR e l'outcome. -correlazione tra risposta dopo due cicli e EFS oculare a 12 mesi. -percentuale funzione visiva a distanza dei pazienti avviati a trattamento conservativo. -incidenza tossicità acuta e a distanza, soprattutto ototossicità, in pazienti avviati a trattamento chemioterapico;Timepoint(s) of evaluation of this end point: Every year until 10 years from stdy inclusion	—

Measure

Time frame

Secondary end point(s): -concordanza tra la stadiazione IRSS e CSIR e l'outcome. -correlazione tra risposta dopo due cicli e EFS oculare a 12 mesi. -percentuale funzione visiva a distanza dei pazienti avviati a trattamento conservativo. -incidenza tossicità acuta e a distanza, soprattutto ototossicità, in pazienti avviati a trattamento chemioterapico;Timepoint(s) of evaluation of this end point: Every year until 10 years from stdy inclusion

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Countries

Italy

Contacts

Public ContactTIZIANA LANDI

AIEOP

tiziana.landi2@unibo.it051/6364667

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026