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Type(s) of Cancer
Sarcoma
Study Phase
Phase 3
Study Completion Date
2010-01
NCT00354744Uploaded 05-25-2019
Access via NCI by Request
PDS UID: nci-data-387
Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma
Provider Information
Provider Data DescriptionNCT00354744-D2 This dataset contains incidence of adverse events as reported in the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.
ConditionsSarcoma
Intervention TypeBiological: dactinomycin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Biological: filgrastim
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Total Enrolled109
RandomizationNa
Blinding MethodNone
Arms InterventionHigh Risk Rhabdomyosarcoma - Experimental
Secondary IDCDR0000489215
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Puerto Rico
Switzerland
Age Range49 Years and younger (CHILD, ADULT)
Files: NCT00354744-D2
Data DictionaryNCT00354744-D2-Data-Dictionary.pdf
DATANCT00354744-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00354744-D1
Data DictionaryNCT00354744-D1-Data-Dictionary.pdf
DATANCT00354744-D1-Dataset.csv
OTHERREADME.pdf
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