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Type(s) of Cancer
Sarcoma
Study Phase
Phase 3
Study Completion Date
2021-03-31
NCT02306161Uploaded 08-31-2024
Access via NCI by Request
PDS UID: nci-data-553
Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Provider Information
Provider Data DescriptionD1: There are 5 datasets associated with the PMID 36669140: NCT02306161-D1 through NCT02306161-D5. This dataset, NCT02306161-D1, provides the information for the CONSORT diagram, text of the document, table 1: patient characteristics, figure 3: Kaplan-Meier curves, supplemental table A1: sites of metastasis, supplemental table A2: mode of primary site local control, and the estimates in supplemental tables A3 and A4: EFS and cumulative incidence of first progression, respectively. There is one row per patient.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether adding ganitumab to combination chemotherapy is more effective in treating patients with newly diagnosed metastatic Ewing sarcoma.
ConditionsMetastatic Ewing Sarcoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Neoplasm in the Bone Marrow
Metastatic Malignant Neoplasm in the Lung
Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone
Peripheral Primitive Neuroectodermal Tumor of Soft Tissues
Intervention TypeDrug: Cyclophosphamide
Drug: Doxorubicin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Etoposide Phosphate
Radiation: External Beam Radiation Therapy
Biological: Ganitumab
Drug: Ifosfamide
Radiation: Stereotactic Radiosurgery
Procedure: Therapeutic Surgical Procedure
Drug: Vincristine
Drug: Vincristine Sulfate
Drug(s)Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Etoposide Phosphate
Drug: Ifosfamide
Drug: Vincristine
Drug: Vincristine Sulfate
Total Enrolled312
RandomizationRandomized
Blinding MethodNone
Arms InterventionRegimen A (VDC/IE) - Experimental
Regimen B (VDC/IE + ganitumab) - Experimental
Secondary IDNCI-2014-02380
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Canada
Puerto Rico
Age Range50 Years and younger (CHILD, ADULT)
Files: NCT02306161-D1
Data DictionaryNCT02306161-D1-Data-Dictionary.pdf
DATANCT02306161-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT02306161-D2
Data DictionaryNCT02306161-D2-Data-Dictionary.pdf
DATANCT02306161-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT02306161-D3
Data DictionaryNCT02306161-D3-Data-Dictionary.pdf
DATANCT02306161-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT02306161-D4
Data DictionaryNCT02306161-D4-Data-Dictionary.pdf
DATANCT02306161-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT02306161-D5
Data DictionaryNCT02306161-D5-Data-Dictionary.pdf
DATANCT02306161-D5-Dataset.csv
OTHERREADME.pdf
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