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Retinoblastoma

Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma

Unique Dataset IDnci-data-411ClinicalTrial.gov IDNCT00079417
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients28RandomizationN/APubMed (PMID)28019092.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeOther, Radiation, Drug, SurgeryDataset TypeOther

Clinical Trial Title

Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma

Trial Summary and Conditions

This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.

Data Summary

See Data Dictionary.

Study Objectives

PRIMARY OBJECTIVES: I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy. SECONDARY OBJECTIVES: I. Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients; II. Correlate response rate with event-free survival in patients treated with this regimen; III. Determine the incidence of toxic effects in patients treated with this regimen.

Outcome Measures

PRIMARY OUTCOME MEASURES: 1. Event-free Survival. SECONDARY OUTCOME MEASURES: 1. Response Rate (RR) at Patient Level After the First Course of Therapy; 2. Response Rate (RR) at Eye Levels After the First Course of Therapy; 3. Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level; 4. Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

NCT00079417-D1 Blanks represent missing data or not applicable for analysis. The CONSORT diagram (manuscript Figure 2) can be reconstructed with the variable consort1 through consort4. The dataset contains one line for every patient enrolled on ARET0331. Table 1, Table 2, Figure 3 and the cumulative incidence calculations can be calculated from this data set.

Available Downloads: NCT00079417-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00079417-D1-Data-Dictionary_2.pdf

DATA: NCT00079417-D1-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00079417-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00079417-D2-Data-Dictionary_2.pdf

DATA: NCT00079417-D2-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00079417-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00079417-D3-Data-Dictionary_2.pdf

DATA: NCT00079417-D3-Dataset_1.csv

OTHER: README.pdf