Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

NCT01906814 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: yanghs20130507
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinoblastoma

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  measure the disease-free survival rate for the two groups at five years

  five years

Secondary Outcomes (4)

• overall survival

  five years

• safety: side effects of chemotherapy in the Treatment of Retinoblastoma

  five years

• quality of life (PedsQL4.0 scale) in the Treatment of Retinoblastoma

  five years

• economic burden due to chemotherapy

  during chemotherapy (9 weeks for 3-cycle group, and 18 weeks for 6-cycle group)

Study Arms (2)

3 cycles chemotherapy

EXPERIMENTAL

Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for three cycles.

Drug: 3 cycles chemotherapy

6 cycles chemotherapy

ACTIVE COMPARATOR

Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for six cycles.

Drug: 6 cycles chemotherapy

Interventions

3 cycles chemotherapy DRUG

Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for three cycles.

Also known as: vincristine, carboplatin, etoposide.

3 cycles chemotherapy

6 cycles chemotherapy DRUG

Chemotherapy: vincristine 0.05 mg/kg (or 1.5 mg/m2 for children ≥ 3 years of age) on Day 1, carboplatin 18.6 mg/kg (or 560 mg/m2 for children ≥ 3 years of age) on Day 1, etoposide 5.0 mg/kg/day (or 150 mg/ m2 for children ≥ 3 years of age) on Days 1 and 2 and 2. Cycles were repeated every 21 days for six cycles.

Also known as: vincristine, carboplatin, etoposide.

6 cycles chemotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
• Received enucleation in the study eye.
• Monocular retinoblastoma.

You may not qualify if:

• Any previous disease in the study eye.
• Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
• History of chemical intervention for retinoblastoma in the study eye.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fudan University: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 39432296 DERIVED

MeSH Terms

Conditions

Retinoblastoma

Interventions

Vincristine; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Huasheng Yang, Doctor

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: July 24, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)