Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

Retinoblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01906814
• Other study ID #: yanghs20130507
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• 3 cycles chemotherapy
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.
• 6 cycles chemotherapy
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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	measure the disease-free survival rate for the two groups at five years	five years
Secondary	overall survival	time from randomization to death as a result of any cause at five years	five years
Secondary	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.	five years
Secondary	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.	five years
Secondary	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.	during chemotherapy (9 weeks for 3-cycle group, and 18 weeks for 6-cycle group)