NCT02137928

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 19, 2014

Status Verified

August 1, 2014

Enrollment Period

9.9 years

First QC Date

May 10, 2014

Last Update Submit

December 18, 2014

Conditions

Retinoblastoma

Keywords

Retinoblastomacarboplatin

Outcome Measures

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

    two years

Secondary Outcomes (1)

  • side effects of carboplatin periocular injection in the Treatment of Retinoblastoma

    two years

Study Arms (2)

carboplatin periocular injection

EXPERIMENTAL

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

chemotherapy

ACTIVE COMPARATOR

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

Drug: chemotherapy

Interventions

carboplatin periocular injectionDRUG

20mg/2ml carboplatin periocular injection together with chemotherapy

Also known as: carboplatin, vincristine, carboplatin, etoposide
carboplatin periocular injection
chemotherapyDRUG

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

Also known as: vincristine, carboplatin, etoposide
chemotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 â…¡ base on International Retinoblastoma Staging System.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Interventions

CarboplatinVincristineEtoposideDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesTherapeutics

Study Officials

  • Huasheng Yang, Doctor

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Huasheng Yang, M.D, PHD

CONTACT

+8620-87331539yanghs64@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 10, 2014

First Posted

May 14, 2014

Study Start

January 1, 2006

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 19, 2014

Record last verified: 2014-08

Locations

CN(1)