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Clinical Trial NCT01906814 for Retinoblastoma is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation Phase 3 179

Active, not recruiting
Clinical Trial NCT01906814 is designed to study Treatment for Retinoblastoma. It is a Phase 3 interventional study that is active, not recruiting, having started on August 1, 2013, with plans to enroll 179 participants. Led by Sun Yat-sen University, it is expected to complete by April 1, 2024. The latest data from ClinicalTrials.gov was last updated on April 9, 2024.
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.
Official Title

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

Conditions
Retinoblastoma
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • yanghs20130507
NCT ID Number
NCT01906814
Start Date (Actual)
2013-08
Last Update Posted
2024-04-09
Completion Date (Estimated)
2024-04
Enrollment (Estimated)
179
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental3 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.
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.
Active Comparator6 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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
disease-free survival
measure the disease-free survival rate for the two groups at five years
five years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
overall survival
time from randomization to death as a result of any cause at five years
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.
five years
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
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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  • 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.

  • 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.
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Study Responsible Party
Huasheng Yang, Principal Investigator, Sun Yat-sen University
No contact data.
1 Study Locations in 1 Countries

Guangdong

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, 510000, China