NCT03475121

Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma

GALOP II Protocol for the Treatment of Unilateral Retinoblastoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Hospital JP Garrahan · Other Government
• Sex: All
• Age: 0 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with non-metastatic retinoblastoma undergoing enucleation will be staged using the American Joint Committee on Cancer (AJCC), version 8, Tumor, Node, Metastasis (TNM)- H system and the International Retinoblastoma Staging System (IRSS). IRSS stage I patients recognized as higher risk will be assigned for adjuvant therapy. Those with standard risk will not receive adjuvant therapy after enucleation. Higher risk patients are defined as those with pathological retrolaminar optic nerve invasion and-or any degree of scleral invasion (pT3b, pT3c, pT3d). Based on the results of the GALOP I protocol, they will receive a reduced dose adjuvant chemotherapy regimen with 3 cycles of alternating cyclophosphamide, vincristine and idarubicin alternating with another 3 cycles of carboplatin and etoposide. Six doses of intrathecal topotecan will be given. Patients presenting with severe buphthalmia (cT3c-cT3e) will receive neo-adjuvant therapy with the same intensive regimen but including a higher dose of carboplatin as per GALOP I protocol plus intrathecal topotecan and secondary enucleation followed by adjuvant chemotherapy for a total of 8 cycles. Stage II patients (pT4) will receive the same adjuvant regimen plus orbital radiotherapy (45 cGy).

Conditions

• Unilateral Retinoblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-01-31
• Completion: 2025-03-28
• First posted: 2018-03-23
• Last updated: 2025-04-13

Locations

1 site across 1 country: Argentina