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Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

Primary Purpose

Retinoblastoma

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
3 cycles chemotherapy
6 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 University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3 cycles chemotherapy

6 cycles chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall survival
time from randomization to death as a result of any cause at five years
safety: side effects of chemotherapy in the Treatment of Retinoblastoma
Number of participants with side effects (systemic check-up, audio acuity, ect)before each treatment, at 1,3,6,9,12,18,24,30,36,42,48,54,60 months after the treatment.
quality of life (PedsQL4.0 scale) in the Treatment of Retinoblastoma
quality of life (PedsQL4.0 scale) before each treatment, at 1,3,6,9,12,18,24,30,36,42,48,54,60 months after the treatment. PedsQL 4.0 questionnaire has two modules (reported by parents and children) with 23 items encompassing the physical domains (8 items), emotional (5 items), social (5 items) and school (5 items). A five scores scale is used, after being asked, ''How much, in the last month, your child has had problems with'' (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = is often a problem and 4 = almost always a problem). The items are reverse-score and linearly transformed to a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4 = 0). So high scores indicate better QoL.
economic burden due to chemotherapy
All costs, including direct cost and indirect cost, are expressed in Chinese YUAN. Direct costs include the average cost of systemic chemotherapy, operation, supportive treatment, and examination. Indirect costs include accommodation, transportation, diet, and lost income of parents.

Full Information

First Posted
July 20, 2013
Last Updated
September 2, 2023
Sponsor
Sun Yat-sen University
Collaborators
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01906814
Brief Title
Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation
Official Title
Three Cycles Versus Six Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Fudan 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 whether 3 cycles of chemotherapy(CEV) is not inferior to 6 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 unilateral Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles every 21 days. 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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 cycles chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
6 cycles chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
3 cycles chemotherapy
Other Intervention Name(s)
vincristine, carboplatin, etoposide.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
6 cycles chemotherapy
Other Intervention Name(s)
vincristine, carboplatin, etoposide.
Intervention Description
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.
Primary Outcome Measure Information:
Title
disease-free survival
Description
measure the disease-free survival rate for the two groups at five years
Time Frame
five years
Secondary Outcome Measure Information:
Title
overall survival
Description
time from randomization to death as a result of any cause at five years
Time Frame
five years
Title
safety: side effects of chemotherapy in the Treatment of Retinoblastoma
Description
Number of participants with side effects (systemic check-up, audio acuity, ect)before each treatment, at 1,3,6,9,12,18,24,30,36,42,48,54,60 months after the treatment.
Time Frame
five years
Title
quality of life (PedsQL4.0 scale) in the Treatment of Retinoblastoma
Description
quality of life (PedsQL4.0 scale) before each treatment, at 1,3,6,9,12,18,24,30,36,42,48,54,60 months after the treatment. PedsQL 4.0 questionnaire has two modules (reported by parents and children) with 23 items encompassing the physical domains (8 items), emotional (5 items), social (5 items) and school (5 items). A five scores scale is used, after being asked, ''How much, in the last month, your child has had problems with'' (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = is often a problem and 4 = almost always a problem). The items are reverse-score and linearly transformed to a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4 = 0). So high scores indicate better QoL.
Time Frame
five years
Title
economic burden due to chemotherapy
Description
All costs, including direct cost and indirect cost, are expressed in Chinese YUAN. Direct costs include the average cost of systemic chemotherapy, operation, supportive treatment, and examination. Indirect costs include accommodation, transportation, diet, and lost income of parents.
Time Frame
during chemotherapy (9 weeks for 3-cycle group, and 18 weeks for 6-cycle group)

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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, Doctor
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

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