Trial | NCT03475121  Report issue

Title

Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma
GALOP II Protocol for the Treatment of Unilateral Retinoblastoma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    200
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.
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).
Study Started
Jan 01
2018
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2025
Anticipated
Last Update
Aug 06
2019

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.

Low Risk Patients Experimental

Patients with IRSS stage I, pT1, pT2 and pT3 stage will not receive adjuvant therapy

Higher Risk Patients Experimental

Patients with IRSS stage I, pT3b, pT3c, pT3d will receive 6 cycles of adjuvant chemotherapy plus 6 doses of intrathecal topotecan

Stage II Patients Experimental

Patients with Stage II (pT4) will receive 6 cycles of adjuvant chemotherapy plus 6 doses of intrathecal topotecan and orbital radiotherapy

Patients with buphthalmus Experimental

Patients with buphthalmus (cT3c, cT3e) will receive 2 cycles of neo-adjuvant chemotherapy plus 6 doses of intrathecal topotecan followed by secondary enucleation and 6 cycles of adjuvant chemotherapy.

Criteria 

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
No Results Posted