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Type(s) of Cancer
Eye
Study Phase
Phase 3
Study Completion Date
2013-02-01
NCT00072384Uploaded 06-08-2021
Access via NCI by Request
PDS UID: nci-data-471
A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma
Provider Information
Provider Data DescriptionNCT00072384 - D1 Dataset Description: NCT00072384 - D1 is one of 5 data submissions associated with PubMed ID 32589362. This dataset provides the information for patients who were enrolled on ARET0231. There is one row for each patient enrolled. The dataset provides the information of baseline characteristics, eye stage from local and central review, outcome data and ocular toxicity on ARET0231 as reported in the manuscript. It is used to generate the Summary of Baseline Characteristics for eligible patients (Table 1), and the information in the beginning of Section 3 Results, Section 3.2 Patterns of intraocular recurrence, Section 3.3 Extraocular recurrence/deaths, and Section 3.4 Ocular toxicity.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryPhase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) retinoblastoma.
ConditionsIntraocular Retinoblastoma
Intervention TypeDrug: liposomal vincristine sulfate
Procedure: cryosurgery
Procedure: laser surgery
Drug: carboplatin
Drug: etoposide
Biological: filgrastim
Drug(s)Drug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide
Total Enrolled30
RandomizationNa
Blinding MethodNone
Arms InterventionTreatment (chemotherapy, surgery) - Experimental
Secondary IDNCI-2009-00420
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range17 Years and younger (CHILD)
Files: NCT00072384-D1
Data DictionaryNCT00072384-D1-Data-Dictionary.pdf
DATANCT00072384-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00072384-D2
Data DictionaryNCT00072384-D2-Data-Dictionary.pdf
DATANCT00072384-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00072384-D3
Data DictionaryNCT00072384-D3-Data-Dictionary.pdf
DATANCT00072384-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00072384-D4
Data DictionaryNCT00072384-D4-Data-Dictionary_1.pdf
DATANCT00072384-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00072384-D5
Data DictionaryNCT00072384-D5-Data-Dictionary_1.pdf
DATANCT00072384-D5-Dataset_2.csv
OTHERREADME.pdf
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