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NCT Number: NCT05080010

Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Huasheng Yang, M.D, PHD

CONTACT

[email protected]

+8620-87331539

About this study

This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

3 cycles chemotherapy

Drug

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

Other names: vincristine, carboplatin, etoposide

Primary outcomes

  1. disease-free survival

    Time frame: five years

    measure the disease-free survival rate at five years

Study contacts

Contact information is provided by the study sponsor or research team.

Huasheng Yang, M.D, PHD

CONTACT

[email protected]

+8620-87331539

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Oct 15, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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