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Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

NCT01906814 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

  • Retinoblastoma

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Huasheng Yang, Doctor · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01906814 on ClinicalTrials.gov