Clinical Trial Finder

Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

Study 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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT01906814

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sun Yat-sen University

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Retinoblastoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000

Site Contact

Huasheng Yang, M.D, PHD

yanghs64@126.com

+8620-87331539

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