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Type(s) of Cancer
Eye
Study Phase
Phase 3
Study Completion Date
September 2011
NCT00335738Uploaded 02-16-2021
Access via NCI by Request
PDS UID: nci-data-448
A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy
Provider Information
Provider Data DescriptionNCT00335738-D1 is one of 2 data submissions associated with PubMed ID 31539297. There is one row for each patient enrolled. The dataset provides the information of consort flow of patient enrollment, baseline characteristics, central pathology review results, and outcome data on ARET0332 as reported in the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, no additional treatment is needed for the tumor until it progresses. In this case, observation may be sufficient.
ConditionsIntraocular Retinoblastoma
Intervention TypeDrug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide
Drug(s)Drug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide
Total Enrolled331
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionGroup 1 (identified by central review as high risk) - Experimental
Group 2 (identified by central review as not high risk) - No Intervention
Secondary IDNCI-2009-00423
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
India
New Zealand
Age Range6 Years and younger (Child)
Files: NCT00335738-D1
Data DictionaryNCT00335738-D1-Data-Dictionary_0.pdf
DATANCT00335738-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00335738-D2
Data DictionaryNCT00335738-D2-Data-Dictionary_1.pdf
DATANCT00335738-D2-Dataset_1.csv
OTHERREADME.pdf
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