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← Soft Tissue Sarcoma

NCT01055314 · STUDY IN CONTEXT

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

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.

primary · POSTED

Proportion of no Grade 3+ cardiac toxicity.

18 participants were excluded because of ineligibility or insufficient information to assess feasibility.

→

primary · POSTED

Proportion of no Grade 4+ non-hematologic toxicity.

13 participants were excluded because of ineligibility or insufficient information to assess feasibility.

→

primary · POSTED

Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.

9 participants who were ineligible or did not receive treatment were excluded.

→

primary · POSTED

Probability of no relapse, secondary malignancy, or death after 3 years in the study.

9 participants who were ineligible or did not receive treatment were excluded.

→

secondary · POSTED

Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \> 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.

20 participants were excluded because of ineligibility or absence in overall response evaluation.

→

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-soft-tissue-sarcoma
nct id
NCT01055314
trial label
Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
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
5
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0000
    source section id
    NCT01055314-om-0000
    source outcome index
    0
    endpoint
    Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment
    endpoint definition
    Proportion of no Grade 3+ cardiac toxicity.
    time origin
    From start to week 26 of therapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    18 participants were excluded because of ineligibility or insufficient information to assess feasibility.
    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-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0001
    source section id
    NCT01055314-om-0001
    source outcome index
    1
    endpoint
    Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment
    endpoint definition
    Proportion of no Grade 4+ non-hematologic toxicity.
    time origin
    From start to week 26 of therapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    13 participants were excluded because of ineligibility or insufficient information to assess feasibility.
    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-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0002
    source section id
    NCT01055314-om-0002
    source outcome index
    2
    endpoint
    Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0
    endpoint definition
    Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.
    time origin
    Up to 54 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    9 participants who were ineligible or did not receive treatment were excluded.
    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-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0003
    source section id
    NCT01055314-om-0003
    source outcome index
    3
    endpoint
    Event-Free Survival
    endpoint definition
    Probability of no relapse, secondary malignancy, or death after 3 years in the study.
    time origin
    3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    9 participants who were ineligible or did not receive treatment were excluded.
    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-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0004
    source section id
    NCT01055314-om-0004
    source outcome index
    4
    endpoint
    Response Rate (CR + PR)
    endpoint definition
    Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \> 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.
    time origin
    From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    20 participants were excluded because of ineligibility or absence in overall response evaluation.
    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-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0000
    arm key
    OG000
    arm label
    IMC-A12
    regimen
    IMC-A12 + Multi-agent intensive chemotherapy regimen.
    analyzed count
    82
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Temozolomide
    regimen
    Add temozolomide to vincristine/irinotecan cycles.
    analyzed count
    62
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0002
    arm key
    OG000
    arm label
    IMC-A12
    regimen
    IMC-A12 + Multi-agent intensive chemotherapy regimen.
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Temozolomide
    regimen
    Add temozolomide to vincristine/irinotecan cycles.
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0002#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0003
    arm key
    OG000
    arm label
    IMC-A12
    regimen
    IMC-A12 + Multi-agent intensive chemotherapy regimen.
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Temozolomide
    regimen
    Add temozolomide to vincristine/irinotecan cycles.
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0003#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0004
    arm key
    OG000
    arm label
    IMC-A12
    regimen
    IMC-A12 + Multi-agent intensive chemotherapy regimen.
    analyzed count
    90
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0004#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Temozolomide
    regimen
    Add temozolomide to vincristine/irinotecan cycles.
    analyzed count
    65
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01055314-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-soft-tissue-sarcoma
    nct id
    NCT01055314
    harm key
    EG000
    source section id
    NCT01055314-ae
    event group key
    EG000
    event group label
    Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
    serious affected
    79
    serious at risk
    96
    other affected
    85
    other at risk
    96
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Nine participants who were ineligible or did not receive treatment were excluded (both serious and other).
    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-soft-tissue-sarcoma
    nct id
    NCT01055314
    harm key
    EG001
    source section id
    NCT01055314-ae
    event group key
    EG001
    event group label
    Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)
    serious affected
    40
    serious at risk
    70
    other affected
    63
    other at risk
    70
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Nine participants who were ineligible or did not receive treatment were excluded (both serious and other).
    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