CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

NCT02319486 | Completed Phase 4 Results DMC

• 1 other identifier: yanghs04
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Conditions

Retinoblastoma

Keywords

Retinoblastoma; carboplatin

Outcome Measures

Primary Outcomes (1)

• Event Free Survival Rate

  measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis

  18 months

Study Arms (1)

CEV with/without carboplatin

EXPERIMENTAL

CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection

Drug: carboplatin periocular injection; Drug: CEV chemotherapy

Interventions

carboplatin periocular injection DRUG

chemotherapy together with/without 20mg/2ml carboplatin periocular injection

Also known as: carboplatin

CEV with/without carboplatin

CEV chemotherapy DRUG

vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2

Also known as: carboplatin,vincristine, etoposide

CEV with/without carboplatin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IRSS stage II or stage IIIa RB patients.
• for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy.
• no tumor-related treatment was given prior to this chemotherapy regimen.

You may not qualify if:

• metastasis, including lymph node metastasis.
• the diagnosis of IRSS stage I or above in the non-target eye.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Retinoblastoma

Interventions

Carboplatin; Vincristine; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Huasheng Yang
• Organization: Zhongshan Ophthalmic Center, Sun Yat-sen University

yanghs64@126.com

+862087331539

Study Officials

• Huasheng Yang, M.D, PHD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Huasheng Yang

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: January 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 30, 2015
• Results First Posted: March 30, 2015

Record last verified: 2015-03