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Type(s) of Cancer
Sarcoma
Study Phase
Phase 3
Study Completion Date
2020-03-31
NCT01231906Uploaded 08-18-2023
Access via NCI by Request
PDS UID: nci-data-523
A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma
Provider Information
Provider Data DescriptionNCT01231906-D1: There are 2 datasets associated with the PMID 34652968: NCT01231906-D1 through NCT01231906-D2. This dataset, NCT01231906-D1, provides the information for the Tables, Figures, and the CONSORT diagram. There is one row per patient. The contents of this submission reflect the correct data described in the July 15, 2022 erratum (PMID 35839523).
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis trial examined the outcome benefit to patients of adding a new chemotherapy drug combination to the established treatment approach for patients with extracranial Ewing sarcoma, that had not spread from the primary site to other places in the body. The trial randomly assigned patients at the time of study entry to receive established standard treatment with the following 5-drugs: vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide and etoposide. The outcome for patients receiving the standard 5-drug combination was compared to the outcome for patients who received the same 5-drugs with an additional drug, topotecan hydrochloride delivered in a novel combination with vincristine sulfate and cyclophosphamide.
ConditionsLocalized Extraskeletal Ewing Sarcoma
Peripheral Primitive Neuroectodermal Tumor of Bone
Peripheral Primitive Neuroectodermal Tumor of Soft Tissues
Intervention TypeDrug: Cyclophosphamide
Drug: Dexrazoxane
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Ifosfamide
Other: Laboratory Biomarker Analysis
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate
Drug(s)Drug: Cyclophosphamide
Drug: Dexrazoxane
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Ifosfamide
Drug: Vincristine Sulfate
Drug: Topotecan Hydrochloride
Total Enrolled642
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A (combination chemotherapy) - Experimental
Arm B (combination chemotherapy, topotecan hydrochloride) - Experimental
Secondary IDNCI-2011-02611
PubMed (PMID)34652968
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Saudi Arabia
Age Range50 Years and younger (CHILD, ADULT)
Files: NCT01231906-D1
Data DictionaryNCT01231906-D1-Data-Dictionary_2.pdf
DATANCT01231906-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01231906-D2
Data DictionaryNCT01231906-D2-Data-Dictionary_1.pdf
DATANCT01231906-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01231906-D3
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