MedTrace Logo

Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma

NCT03475121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-04-13

No results posted yet for this study

Summary

This protocol provides guidelines for the management of non-metastatic unilateral retinoblastoma and introduces an innovative adjuvant therapy for higher risk patients based upon the results of the Grupo de America Latina de Oncologia Pediatrica (GALOP) I study. Conservative therapy will be not protocolized.

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.

Sponsors & Collaborators

  • Hospital JP Garrahan

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-01-31
Completion
2025-03-28

Countries

  • Argentina

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475121 on ClinicalTrials.gov