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Status unknownNCT02137928Updated Dec 19, 2014

Carboplatin Periocular Injection for Retinoblastoma

A Phase 3 interventional study of carboplatin periocular injection and chemotherapy in Retinoblastoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2014-12-19.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study summary

This study will evaluate the clinical efficacy of periocular injections of carboplatin together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.

Read the detailed description

This study will be a phase Ⅲ open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive carboplatin periocular on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .

02

Conditions studied

  • Retinoblastoma

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Keywords

  • Retinoblastoma
  • carboplatin
03

In context

Retinoblastoma

126 studies on the registry are indexed under Retinoblastoma; 23 are open to participants now.

This study's planned enrollment of 50 is above the median of 30 across 79 interventional studies indexed under Retinoblastoma.

Browse Retinoblastoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma Staging System.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    carboplatin periocular injection

    20mg/2ml carboplatin periocular injection together with CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months)

    Drug: carboplatin periocular injection

  • Active comparator
    chemotherapy

    Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months

    Drug: chemotherapy

Interventions

  • 20mg/2ml carboplatin periocular injection together with chemotherapy

    Also known as: carboplatin, vincristine, carboplatin, etoposide

  • Drugchemotherapy

    Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.

    Also known as: vincristine, carboplatin, etoposide

06

What researchers measure

Primary outcomes

  1. all cause mortality

    measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years

    Time frame: two years

Secondary outcomes

  1. side effects of carboplatin periocular injection in the Treatment of Retinoblastoma

    Measure the side effects(systemic check-up, local side effects) before each treatment, and 1,3,6,9,12,18,24 months after the treatment.

    Time frame: two years

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2006, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2014
First posted
May 14, 2014
Start
Jan 2006
Primary completionEst.
Dec 2015
CompletionEst.
Dec 2015
Last update
Dec 19, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02137928
Responsible party
Huasheng Yang (professor, Sun Yat-sen University) — Principal investigator
First posted
May 14, 2014
Start date
Jan 2006
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Dec 19, 2014

Study contacts

Huasheng Yang, M.D, PHD
Contact
yanghs64@126.com
+8620-87331539
Huasheng Yang, Doctor
study chair · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Carboplatin

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