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Type(s) of Cancer
Eye
Study Phase
Phase 3
Study Completion Date
2010-01-01
NCT00079417Uploaded 04-28-2020
Access via NCI by Request
PDS UID: nci-data-411
Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
Provider Information
Provider Data DescriptionNCT00079417-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.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsIntraocular Retinoblastoma
Intervention TypeDrug: Carboplatin
Procedure: Cryosurgery
Procedure: Infrared Laser Therapy
Radiation: Iodine I-125
Radiation: Radiation Therapy
Radiation: Ruthenium Ru-106
Drug: Vincristine Sulfate
Drug(s)Drug: Carboplatin
Drug: Vincristine Sulfate
Total Enrolled28
RandomizationNa
Blinding MethodNone
Arms InterventionTreatment (chemotherapy, surgery) - Experimental
Secondary IDNCI-2009-00422
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range5 Years and younger (CHILD)
Files: NCT00079417-D1
Data DictionaryNCT00079417-D1-Data-Dictionary_2.pdf
DATANCT00079417-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00079417-D2
Data DictionaryNCT00079417-D2-Data-Dictionary_2.pdf
DATANCT00079417-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00079417-D3
Data DictionaryNCT00079417-D3-Data-Dictionary_2.pdf
DATANCT00079417-D3-Dataset_1.csv
OTHERREADME.pdf
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