PROTOCOL FOR THE DIAGNOSIS AND THERAPY OF INTRAOCULAR RETINOBLASTOMA

PROTOCOL FOR THE DIAGNOSIS AND THERAPY OF INTRAOCULAR RETINOBLASTOMA - RTB AIEOP 018

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000742-35-IT

Enrollment

Registered

2021-05-24

Start date

2021-05-05

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Intraocular retinoblastoma MedDRA version: 20.0 Level: PT Classification code 10038916 Term: Retinoblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10038916 Term: Retinoblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10038916 Term: Retinoblastoma System Organ Class: 10029104

Interventions

Product Name: Carboplatino Product Code: [Carbo] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Carboplatino CAS Number: 41575-94-4 Current Sponsor code: Carboplatino

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Clinical diagnosis of single or bilateral intraocular Retinoblastoma (stage 0 according to "International Retinoblastoma Staging System-IRSS") • Patients =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients = 16 years old • Patients not evaluated with panormic Fundus-Cam at diagnosis • Patients who have received prior chemo or radiotherapy treatments • Ongoing pregnancy or breastfeeding • Hypersensitivity to any component of the study drugs • Vaccination with live and attenuated virus • Subjects with neuromuscular disorders • Presence of exclusion criteria for conservative treatment • Absence of eligibility criteria for the study

Design outcomes

Primary

Measure	Time frame
Main Objective: For patients with intraocular retinoblastoma, the main objective is to achieve at least 60% ocular survival, 24 months after diagnosis, through the proposed conservative treatment scheme, without recourse to TEN or secondary enucleation ( EFS). The proposed conservative treatment scheme, detailed in paragraph 5, provides for the introduction in the first line of chemotherapy by intra-arterial (Melphalan and Topotecan), intravitreal (Melphalan) and peribulbar (Carboplatin and Topotecan) routes.;Secondary Objective: TOXICITY The evaluate the systemic and local toxicity, short, medium and long term, of systemically or locally administered chemotherapy (intra-arterial, intravitreal and peribulbar) and focal eye treatments VISUAL OUTCOME To evaluate the residual visual function, at distance, of patients in conservative treatment. CLASSIFICATION SYSTEM To prospectively validate the 8th edition of the TNM Staging System (69) for the staging of intraocular disease, and for analysis of the histological risk factors of the enucleated eyeball d'emblée or post conservative treatment;Primary end point(s): ocular EFS;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: For patients with intraocular retinoblastoma, the main objective is to achieve at least 60% ocular survival, 24 months after diagnosis, through the proposed conservative treatment scheme, without recourse to TEN or secondary enucleation ( EFS). The proposed conservative treatment scheme, detailed in paragraph 5, provides for the introduction in the first line of chemotherapy by intra-arterial (Melphalan and Topotecan), intravitreal (Melphalan) and peribulbar (Carboplatin and Topotecan) routes.;Secondary Objective: TOXICITY The evaluate the systemic and local toxicity, short, medium and long term, of systemically or locally administered chemotherapy (intra-arterial, intravitreal and peribulbar) and focal eye treatments VISUAL OUTCOME To evaluate the residual visual function, at distance, of patients in conservative treatment. CLASSIFICATION SYSTEM To prospectively validate the 8th edition of the TNM Staging System (69) for the staging of intraocular disease, and for analysis of the histological risk factors of the enucleated eyeball d'emblée or post conservative treatment;Primary end point(s): ocular EFS;Timepoint(s) of evaluation of this end point: 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): Medium and long-term systemic and ocular toxicity; visual outcome; Validation of the 8th edition of the TNM Staging System as a staging system;Timepoint(s) of evaluation of this end point: NA; 4 years; NA	—

Countries

Italy

Contacts

Public ContactClinical trial office- Dipartimento

OPBG- Ospedale Pediatrico Bambino Gesu'

mgiuseppina.cefalo@opbg.net0668592292

Outcome results

None listed

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