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Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Active, not recruiting
Phase 3

Conditions

Retinoblastoma

Treatments

Drug: 6 cycles chemotherapy
Drug: 3 cycles chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01906814
yanghs20130507

Details and patient eligibility

About

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.

Full 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.

Enrollment

179 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

179 participants in 2 patient groups

3 cycles chemotherapy
Experimental group
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.
Treatment:
Drug: 3 cycles chemotherapy
6 cycles chemotherapy
Active Comparator group
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.
Treatment:
Drug: 6 cycles chemotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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