NCT03475121View on ClinicalTrials.gov

Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma

PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

January 31, 2023

Study Completion Date

March 28, 2025

Conditions
Unilateral Retinoblastoma
Interventions
COMBINATION_PRODUCT

Combination Chemotherapy plus Intrathecal Topotecan

Adjuvant chemotherapy with a reduced dose (compared to GALOP I protocol) of carboplatin

COMBINATION_PRODUCT

Higher Dose Combination Chemotherapy plus Intrathecal Topotecan

GALOP I-based systemic adjuvant therapy plus intrathecal topotecan

COMBINATION_PRODUCT

Higher Dose Combination Chemotherapy plus Intrathecal Topotecan and Orbital Radiotherapy

GALOP I-based systemic adjuvant therapy plus intrathecal topotecan and orbital radiotherapy (45 Gy) up to chiasm

OTHER

No Adjuvant Therapy

Patients will not receive any adjuvant therapy after enucleation of the affected eye.

Trial Locations (1)

C1245AAL

Hospital JP Garrahan, Buenos Aires

All Listed Sponsors
lead

Hospital JP Garrahan

OTHER_GOV

NCT03475121 - Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma | Biotech Hunter | Biotech Hunter