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Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

This study is currently recruiting participants.
Verified December 2015 by Huasheng Yang, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01906814
First Posted: July 24, 2013
Last Update Posted: December 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Fudan University
Information provided by (Responsible Party):
Huasheng Yang, Sun Yat-sen University
  Purpose
The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) are as effective as 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

Condition Intervention Phase
Retinoblastoma Drug: 3 cycles chemotherapy Drug: 6 cycles chemotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three Cycles Versus Six Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Randomized Control Study

Resource links provided by NLM:


Further study details as provided by Huasheng Yang, Sun Yat-sen University:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: two years ]
    measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years


Secondary Outcome Measures:
  • side effects of chemotherapy in the Treatment of Retinoblastoma [ Time Frame: two years ]
    Measure the side effects(systemic check-up, audio acuity)before each treatment, and 1,3,6,9,12,18,24 months after the treatment.


Estimated Enrollment: 156
Study Start Date: January 2013
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Drug: 3 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Other Name: vincristine, carboplatin, etoposide.
Active Comparator: 6 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Drug: 6 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Other Name: vincristine, carboplatin, etoposide.

Detailed Description:
This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles on a monthly basis. Patients will be followed for 24 months.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906814


Contacts
Contact: Huasheng Yang, M.D, PHD +8620-87331539 yanghs64@126.com

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Huasheng Yang, M.D, PHD    +8620-87331539    yanghs64@126.com   
Sponsors and Collaborators
Sun Yat-sen University
Fudan University
Investigators
Study Chair: Huasheng Yang, Doctor Zhongshan Ophthalmic Center, Sun Yat-sen University
  More Information

Responsible Party: Huasheng Yang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01906814     History of Changes
Other Study ID Numbers: yanghs20130507
First Submitted: July 20, 2013
First Posted: July 24, 2013
Last Update Posted: December 11, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Retinoblastoma
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
Retinal Diseases
Etoposide phosphate
Carboplatin
Etoposide
Vincristine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators