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← Ewing Sarcoma

NCT02306161 · STUDY IN CONTEXT

Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · NOT_POSTED

In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median.

Source null

→

exploratory · NOT_POSTED

Extent of tumor cell IGF-1R co-expression will also be reported. Change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively.

Source null

→

exploratory · NOT_POSTED

EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab.

Source null

→

primary · POSTED

Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.

Only eligible patients are considered in the calculation of this outcome measure.

→

secondary · POSTED

Time from study enrollment to death or last patient contact.

Only eligible patients are considered in the calculation of this outcome measure.

→

secondary · POSTED

The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.

Only eligible patients who received at least one dose of assigned protocol therapy are considered in the calculation of this outcome measure. Five hundred twenty-seven (527) reporting periods were contributed by patients enrolled on Regimen A; Five hundred seventy-six 576 reporting periods were contributed by patients enrolled on Regimen B.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-ewing-sarcoma
nct id
NCT02306161
trial label
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0003
    source section id
    NCT02306161-om-0003
    source outcome index
    3
    endpoint
    Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers
    endpoint definition
    In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median.
    time origin
    Up to 10 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0004
    source section id
    NCT02306161-om-0004
    source outcome index
    4
    endpoint
    Tumor Cell Surface IGF-1R Expression
    endpoint definition
    Extent of tumor cell IGF-1R co-expression will also be reported. Change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively.
    time origin
    Up to 307 days
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0005
    source section id
    NCT02306161-om-0005
    source outcome index
    5
    endpoint
    Germline Polymorphisms in EGFR
    endpoint definition
    EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab.
    time origin
    Up to 10 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0000
    source section id
    NCT02306161-om-0000
    source outcome index
    0
    endpoint
    Event-free Survival
    endpoint definition
    Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
    time origin
    5 years after enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only eligible patients are considered in the calculation of this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0001
    source section id
    NCT02306161-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Time from study enrollment to death or last patient contact.
    time origin
    5 years after enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only eligible patients are considered in the calculation of this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0002
    source section id
    NCT02306161-om-0002
    source outcome index
    2
    endpoint
    Frequency of Toxicity-events
    endpoint definition
    The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.
    time origin
    Up to 202 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only eligible patients who received at least one dose of assigned protocol therapy are considered in the calculation of this outcome measure. Five hundred twenty-seven (527) reporting periods were contributed by patients enrolled on Regimen A; Five hundred seventy-six 576 reporting periods were contributed by patients enrolled on Regimen B.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Regimen A (VDC/IE)
    regimen
    INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    analyzed count
    148
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02306161-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Regimen B (VDC/IE + Ganitumab)
    regimen
    INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    analyzed count
    150
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02306161-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Regimen A (VDC/IE)
    regimen
    INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    analyzed count
    148
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02306161-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Regimen B (VDC/IE + Ganitumab)
    regimen
    INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    analyzed count
    150
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02306161-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Regimen A (VDC/IE)
    regimen
    INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    analyzed count
    145
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02306161-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Regimen B (VDC/IE + Ganitumab)
    regimen
    INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles. Cyclophosphamide: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Etoposide Phosphate: Given IV External Beam Radiation Therapy: Undergo EBRT Ganitumab: Given IV Ifosfamide: Given IV Stereotactic Radiosurgery: Undergo SBRT Therapeutic Surgical Procedure: Undergo surgery Vincristine: Given IV Vincristine Sulfate: Given IV
    analyzed count
    150
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02306161-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    harm key
    EG000
    source section id
    NCT02306161-ae
    event group key
    EG000
    event group label
    Regimen A (VDC/IE)
    serious affected
    3
    serious at risk
    145
    other affected
    114
    other at risk
    145
    frequency threshold
    0
    collection period
    Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ewing-sarcoma
    nct id
    NCT02306161
    harm key
    EG001
    source section id
    NCT02306161-ae
    event group key
    EG001
    event group label
    Regimen B (VDC/IE + Ganitumab)
    serious affected
    45
    serious at risk
    150
    other affected
    122
    other at risk
    150
    frequency threshold
    0
    collection period
    Adverse Events monitored up to 358 days from study enrollment, All-Cause Mortality monitored up to 5 years
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients and those who did not receive therapy are excluded. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice