Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

NCT01906814 ↗

Phase 3 Unknown 179 enrolled Sun Yat-sen University Fudan University · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) is not inferior to 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

Timeline

Start: 2013-08
Primary completion: 2024-04
Completion: 2024-04

Outcome

Met primary endpoint

paper which met the noninferiority criterion (P = .003 for noninferiority). PMID 39432296 ↗

Publications

Ye H, Xue K, Zhang P, Chen R, Zhai X, Ling L, Xiao W, Tang L, Wang H, Mao Y, Ai S, Bi Y, Liu Q, Zou Y, Qian J, Yang H. Three vs 6 Cycles of Chemotherapy for High-Risk Retinoblastoma: A Randomized Clinical Trial. JAMA. 2024 Nov 19;332(19):1634-1641. doi: 10.1001/jama.2024.19981.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	18.6 mg/kg	—
Subject	Carboplatin	Small molecule	560 mg/m2	—
Subject	Etoposide	Small molecule	5 mg/kg	—
Subject	Etoposide	Small molecule	150 mg/m2	—
Subject	Vincristine	Small molecule	0.05 mg/kg	—
Subject	Vincristine	Small molecule	1.5 mg/m2	—