Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Huasheng Yang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01906814
First received: July 20, 2013
Last updated: July 23, 2013
Last verified: July 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Sun Yat-sen University:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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 II 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Huasheng Yang, Doctor Zhongshan Ophthalmic Center, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Huasheng Yang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01906814     History of Changes
Other Study ID Numbers: yanghs20130507
Study First Received: July 20, 2013
Last Updated: July 23, 2013
Health Authority: China: Ethics Committee

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
Vincristine
Etoposide phosphate
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014