Status:
COMPLETED
Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma
Lead Sponsor:
Hospital JP Garrahan
Conditions:
Unilateral Retinoblastoma
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE3
Brief 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 Gr...
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 Intern...
Eligibility Criteria
Inclusion
- 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
- Patients with unilateral retinoblastoma and germline mutations of the Rb1 gene or family history for retinoblastoma
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03475121
Start Date
January 1 2018
End Date
March 28 2025
Last Update
April 13 2025
Active Locations (1)
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1
Hospital JP Garrahan
Buenos Aires, Buenos Aires F.D., Argentina, C1245AAL