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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
March 2012
NCT00302003Uploaded 03-27-2021
Access via NCI by Request
PDS UID: nci-data-463
A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease
Provider Information
Provider Data DescriptionThere are two datasets associated with PMID 29738613: NCT00302003-D1 and NCT00302003-D2. This dataset, NCT00302003-D1, contains all the data except for toxicities. Specifically, this dataset provides all the numbers and statistics presented under the results section and tables and figures of the publication regarding consort flow, patient enrollment, patient and 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
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's 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 more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.
ConditionsChildhood Favorable Prognosis Hodgkin Lymphoma
Childhood Lymphocyte Depletion Hodgkin Lymphoma
Childhood Mixed Cellularity Hodgkin Lymphoma
Childhood Nodular Sclerosis Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Intervention TypeRadiation: radiation therapy
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Drug: ifosfamide
Drug: vinorelbine tartrate
Drug: dexamethasone
Drug: etoposide phosphate
Drug: cisplatin
Drug: cytarabine
Biological: filgrastim
Drug(s)Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Drug: ifosfamide
Drug: vinorelbine tartrate
Drug: dexamethasone
Drug: etoposide phosphate
Drug: cisplatin
Drug: cytarabine
Total Enrolled287
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionDoxorubicin, Vincristine, Cyclophosphamide and Filgrastim - Experimental
Secondary IDNCI-2009-00377
PubMed (PMID)35763667
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range21 Years and younger (Child, Adult)
Files: NCT00302003-D1
Data DictionaryNCT00302003-D1-Data-Dictionary_5.pdf
DATANCT00302003-D1-Dataset_5.csv
OTHERREADME.pdf
Files: NCT00302003-D2
Data DictionaryNCT00302003-D2-Data-Dictionary_4.pdf
DATANCT00302003-D2-Dataset_1.csv
OTHERREADME.pdf
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