Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma

Unilateral Retinoblastoma Clinical Trial

— RbGALOP2  

Official title:

GALOP II Protocol for the Treatment of Unilateral Retinoblastoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03475121
• Other study ID #: 1031. Retinoblastoma GALOP 2
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Hospital JP Garrahan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 6 Years

Eligibility

Inclusion Criteria:

• Histological diagnosis of retinoblastoma confirmed at participating institutions

• Ophthalmological diagnosis of unilateral retinoblastoma in patients undergoing conservative therapy.

• No prior therapy for retinoblastoma

• Lansky Performance Scale greater or equal to 50

• Normal organ function in those patients assigned for chemotherapy

• Signed informed consent

Exclusion Criteria:

• Patients with unilateral retinoblastoma and germline mutations of the Rb1 gene or family history for retinoblastoma

Related Conditions & MeSH terms

• Retinoblastoma
• Unilateral Retinoblastoma

Intervention

Combination Product:
• Combination Chemotherapy plus Intrathecal Topotecan
Adjuvant chemotherapy with a reduced dose (compared to GALOP I protocol) of carboplatin
• Higher Dose Combination Chemotherapy plus Intrathecal Topotecan
GALOP I-based systemic adjuvant therapy plus intrathecal topotecan
• 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.

Locations

Country	Name	City	State
Argentina	Hospital JP Garrahan	Buenos Aires	CF

Sponsors (2)

Lead Sponsor	Collaborator
Hospital JP Garrahan	Hospital San Juan de Dios, Santiago

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of extraocular relapses	Number of participants experiencing extraocular relapse	3 years
Primary	Evaluation of number of patients experiencing acute, chronic and fatal toxicities	Number of participants experiencing treatment-related adverse effects and mortality as measured by CTCAE v4.0	5 years