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Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Primary Purpose

Retinoblastoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
3 cycles chemotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinoblastoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3 cycles chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

disease-free survival
measure the disease-free survival rate at five years

Secondary Outcome Measures

Full Information

First Posted
October 2, 2021
Last Updated
October 2, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05080010
Brief Title
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma
Official Title
Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2030 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 cycles chemotherapy
Arm Type
Experimental
Arm Description
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Intervention Type
Drug
Intervention Name(s)
3 cycles chemotherapy
Other Intervention Name(s)
vincristine, carboplatin, etoposide
Intervention Description
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Primary Outcome Measure Information:
Title
disease-free survival
Description
measure the disease-free survival rate at five years
Time Frame
five years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huasheng Yang, M.D, PHD
Phone
+8620-87331539
Email
yanghs64@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, M.D, PHD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, M.D, PHD
Phone
+8620-87331539
Email
yanghs64@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

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