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← Spindle Cell Sarcoma

NCT02180867 · STUDY IN CONTEXT

Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can

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

The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.

Pediatric patients, excluding 1 ineligible patient in Dose-Finding CR group and 1 ineligible patient in Dose-Finding RT group

→

primary · POSTED

The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.

Adult patients, excluding 1 ineligible patient in Dose-Finding RT group

→

primary · POSTED

A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.

It was pre-specified to combine adult and pediatric participants for analysis as they received an equivalent dose of Pazopanib. There were no patients enrolled onto Dose-Finding Level 0 CR or Dose-Finding Level 2 CR. 19 Regimen A patients and 23 Regimen B patients were excluded.

→

primary · POSTED

A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.

It was pre-specified to combine adult and pediatric participants for analysis as they received an equivalent dose of Pazopanib. There were no patients enrolled onto Dose Level 0 RT. 3 Regimen C patients excluded: 1 patient did not receive treatment and 2 missing review; 4 Regimen D patients excluded due to missing review.

→

primary · POSTED

Time to the first occurrence of relapse, progression, secondary cancer or death from any cause.

Data for the phase III portion of the study were never collected because the RT arm was closed earlier due to slow accrual.

→

secondary · POSTED

Defined as disease recurrence only at the primary site of disease at diagnosis. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.

Patients deemed ineligible in the original cohort are excluded. An additional five (5) patients are excluded in this 5-year analysis as they were deemed ineligible post the initial submission and publication.

→

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

Patient-reported symptom or function measure · Feasible Dose: Pediatric

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-spindle-cell-sarcoma
nct id
NCT02180867
qol key
qol-0000
source section id
NCT02180867-om-0000
source outcome index
0
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Feasible Dose: Pediatric
measure definition
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
time frame
After the first 6 weeks of Induction
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Pediatric patients, excluding 1 ineligible patient in Dose-Finding CR group and 1 ineligible patient in Dose-Finding RT group
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Patient-reported symptom or function measure · Feasible Dose: Adult

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-spindle-cell-sarcoma
nct id
NCT02180867
qol key
qol-0001
source section id
NCT02180867-om-0001
source outcome index
1
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Feasible Dose: Adult
measure definition
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
time frame
After the first 6 weeks of Induction
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Adult patients, excluding 1 ineligible patient in Dose-Finding RT group
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-spindle-cell-sarcoma
nct id
NCT02180867
trial label
Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can
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
7
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0000
    source section id
    NCT02180867-om-0000
    source outcome index
    0
    endpoint
    Feasible Dose: Pediatric
    endpoint definition
    The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
    time origin
    After the first 6 weeks of Induction
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pediatric patients, excluding 1 ineligible patient in Dose-Finding CR group and 1 ineligible patient in Dose-Finding RT group
    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-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0001
    source section id
    NCT02180867-om-0001
    source outcome index
    1
    endpoint
    Feasible Dose: Adult
    endpoint definition
    The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
    time origin
    After the first 6 weeks of Induction
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Adult patients, excluding 1 ineligible patient in Dose-Finding RT group
    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-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0002
    source section id
    NCT02180867-om-0002
    source outcome index
    2
    endpoint
    Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13
    endpoint definition
    A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.
    time origin
    Week 13 after induction
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    It was pre-specified to combine adult and pediatric participants for analysis as they received an equivalent dose of Pazopanib. There were no patients enrolled onto Dose-Finding Level 0 CR or Dose-Finding Level 2 CR. 19 Regimen A patients and 23 Regimen B patients 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-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0003
    source section id
    NCT02180867-om-0003
    source outcome index
    3
    endpoint
    Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10
    endpoint definition
    A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.
    time origin
    Week 10 after induction
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    It was pre-specified to combine adult and pediatric participants for analysis as they received an equivalent dose of Pazopanib. There were no patients enrolled onto Dose Level 0 RT. 3 Regimen C patients excluded: 1 patient did not receive treatment and 2 missing review; 4 Regimen D patients excluded due to missing review.
    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-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0004
    source section id
    NCT02180867-om-0004
    source outcome index
    4
    endpoint
    Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry
    endpoint definition
    Time to the first occurrence of relapse, progression, secondary cancer or death from any cause.
    time origin
    From enrollment to up to 60 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data for the phase III portion of the study were never collected because the RT arm was closed earlier due to slow accrual.
    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-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0005
    source section id
    NCT02180867-om-0005
    source outcome index
    5
    endpoint
    Percentage of Patients Local Failure Free at 5 Years Following Study Entry
    endpoint definition
    Defined as disease recurrence only at the primary site of disease at diagnosis. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.
    time origin
    From enrollment to up to 60 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients deemed ineligible in the original cohort are excluded. An additional five (5) patients are excluded in this 5-year analysis as they were deemed ineligible post the initial submission and publication.
    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-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0000
    arm key
    OG000
    arm label
    All Pediatric Dose Finding CR Cohorts
    regimen
    Dose-Finding CR: Chemoradiation plus pazopanib
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0000
    arm key
    OG001
    arm label
    All Pediatric Dose Finding RT Cohorts
    regimen
    Dose-Finding RT: Radiation therapy plus pazopanib
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0001
    arm key
    OG000
    arm label
    All Adult Dose Finding CR Cohorts
    regimen
    Dose-Finding CR: Chemoradiation plus pazopanib
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0001
    arm key
    OG001
    arm label
    All Adult Dose Finding RT Cohorts
    regimen
    Dose-Finding RT: Radiation therapy plus pazopanib
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Dose-Finding Level 1 CR
    regimen
    Dose-Finding Level 1 CR: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Regimen A
    regimen
    Regimen A: Chemoradiation plus pazopanib
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Regimen B
    regimen
    Regimen B: Chemoradiation alone
    analyzed count
    25
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Dose-Finding Level 1 RT
    regimen
    Dose-Finding Level 1 RT: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Dose-Finding Level 2 RT
    regimen
    Dose-Finding Level 2 RT: Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Regimen C
    regimen
    Regimen C: Radiation therapy plus pazopanib
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0003#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0003
    arm key
    OG003
    arm label
    Regimen D
    regimen
    Regimen D: Radiation therapy alone
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0003#groups/OG003
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Regimen C
    regimen
    Regimen C: Radiation therapy plus pazopanib
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02180867-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    harm key
    EG000
    source section id
    NCT02180867-ae
    event group key
    EG000
    event group label
    Dose-Finding Level 1 CR
    serious affected
    6
    serious at risk
    9
    other affected
    4
    other at risk
    9
    frequency threshold
    0
    collection period
    Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
    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 are excluded from reporting of adverse events. 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-spindle-cell-sarcoma
    nct id
    NCT02180867
    harm key
    EG001
    source section id
    NCT02180867-ae
    event group key
    EG001
    event group label
    Dose-Finding Level 1 RT
    serious affected
    6
    serious at risk
    9
    other affected
    2
    other at risk
    9
    frequency threshold
    0
    collection period
    Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
    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 are excluded from reporting of adverse events. 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    harm key
    EG002
    source section id
    NCT02180867-ae
    event group key
    EG002
    event group label
    Dose-Finding Level 2 RT
    serious affected
    2
    serious at risk
    10
    other affected
    5
    other at risk
    10
    frequency threshold
    0
    collection period
    Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
    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 are excluded from reporting of adverse events. 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    harm key
    EG003
    source section id
    NCT02180867-ae
    event group key
    EG003
    event group label
    Regimen A
    serious affected
    33
    serious at risk
    46
    other affected
    20
    other at risk
    46
    frequency threshold
    0
    collection period
    Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
    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 are excluded from reporting of adverse events. 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    harm key
    EG004
    source section id
    NCT02180867-ae
    event group key
    EG004
    event group label
    Regimen B
    serious affected
    8
    serious at risk
    43
    other affected
    10
    other at risk
    43
    frequency threshold
    0
    collection period
    Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
    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 are excluded from reporting of adverse events. 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    harm key
    EG005
    source section id
    NCT02180867-ae
    event group key
    EG005
    event group label
    Regimen C
    serious affected
    1
    serious at risk
    6
    other affected
    1
    other at risk
    6
    frequency threshold
    0
    collection period
    Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
    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 are excluded from reporting of adverse events. 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
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    harm key
    EG006
    source section id
    NCT02180867-ae
    event group key
    EG006
    event group label
    Regimen D
    serious affected
    0
    serious at risk
    6
    other affected
    0
    other at risk
    6
    frequency threshold
    0
    collection period
    Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
    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 are excluded from reporting of adverse events. 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-spindle-cell-sarcoma
    nct id
    NCT02180867
    qol key
    qol-0000
    source section id
    NCT02180867-om-0000
    source outcome index
    0
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient-reported' in the study's own wording
    scale title
    Feasible Dose: Pediatric
    measure definition
    The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
    time frame
    After the first 6 weeks of Induction
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Pediatric patients, excluding 1 ineligible patient in Dose-Finding CR group and 1 ineligible patient in Dose-Finding RT group
    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-spindle-cell-sarcoma
    nct id
    NCT02180867
    qol key
    qol-0001
    source section id
    NCT02180867-om-0001
    source outcome index
    1
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient-reported' in the study's own wording
    scale title
    Feasible Dose: Adult
    measure definition
    The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
    time frame
    After the first 6 weeks of Induction
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Adult patients, excluding 1 ineligible patient in Dose-Finding RT group
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice