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Type(s) of Cancer
Lymphoma (Hodgkins)
Study Phase
Phase 3
Study Completion Date
March 2012
NCT01026220Uploaded 09-02-2020
Access via NCI by Request
PDS UID: nci-data-424
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma
Provider Information
Provider Data DescriptionNCT01026220-D1 Dataset contains all the data which provides all the numbers, statistics, figures and tables in this publication. The data includes patient demographics, clinical characteristics and survival endpoints. This dataset is presented at patient level and includes one record per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset166
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNCI standard
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
ConditionsChildhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Intervention TypeBiological: bleomycin sulfate
Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: vinorelbine tartrate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Biological: filgrastim
Drug: ifosfamide
Drug(s)Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Drug: vinorelbine tartrate
Drug: ifosfamide
Total Enrolled166
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionRegimen I (consolidation therapy) - Experimental
Regimen II (consolidation therapy) - Experimental
Induction: all patient - Experimental
Secondary IDNCI-2011-01994
PubMed (PMID)NA
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Israel
Puerto Rico
Age RangeMinimum Age: NA
Maximum Age: 21 Years
Files: NCT01026220-D1
Data DictionaryNCT01026220-D1-Data-Dictionary_3.pdf
DATANCT01026220-D1-Dataset_1.csv
OTHERREADME.pdf
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