Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

NCT05080010 | Recruiting Phase 3 DMC

• 1 other identifier: yanghs2020
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of 3 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 at five years

  five years

Study Arms (1)

3 cycles chemotherapy

EXPERIMENTAL

Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.

Drug: 3 cycles chemotherapy

Interventions

3 cycles chemotherapy DRUG

Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.

Also known as: vincristine, carboplatin, etoposide

3 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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

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, M.D, PHD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Huasheng Yang, M.D, PHD

CONTACT

+8620-87331539; yanghs64@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 15, 2021
• Study Start: November 1, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)