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← Osteosarcoma

NCT04154189 · STUDY IN CONTEXT

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcom

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. 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

PFS as assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of PD or date of death (whichever occurred first), as determined using RECIST v1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.

FAS included all randomized participants regardless of the treatment actually received.

→

secondary · POSTED

PFS rate at 4 months as assessed by IIR was defined as the percentage of participants who were alive and without PD at 4 months from the randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. The PFS-4m was estimated using the Kaplan-Meier method.

FAS included all randomized participants regardless of the treatment actually received.

→

secondary · POSTED

PFS-1y rate as assessed by IIR was defined as the percentage of participants who were alive and without PD at 1 year from randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS-1y rate was estimated using Kaplan-Meier method.

FAS included all randomized participants regardless of the treatment actually received.

→

secondary · POSTED

OS was defined as the time from the date of randomization to the date of death from any cause. The median OS was from Kaplan-Meier product-limit estimates and 2-sided 95% CIs from a generalized Brookmeyer and Crowley method.

FAS included all randomized participants regardless of the treatment actually received.

→

secondary · POSTED

OS-1y was defined as the time from the date of randomization to the date of death from any cause assessed up to 1 year. OS was calculated using the Kaplan-Meier method.

FAS included all randomized participants regardless of the treatment actually received.

→

secondary · POSTED

ORR-4m was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined by IIR using RECIST v1.1 within the first 4 months. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 95% confidence interval (CI) of ORR was calculated using the method of Clopper and Pearson.

FAS included all randomized participants regardless of the treatment actually received.

→

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

Unnamed quality-of-life measure · Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scale: Generic Core Scale Score at Month 4

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-osteosarcoma
nct id
NCT04154189
qol key
qol-0009
source section id
NCT04154189-om-0009
source outcome index
9
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scale: Generic Core Scale Score at Month 4
measure definition
Health-Related Quality of Life (HRQoL): PedsQL 4.0 Generic Core Scale is a multidimensional scale. It included assessment of 4 dimensions: physical functioning (8 items), emotional functioning (8 items), social functioning (8 items), and school functioning (5 items - children greater than or equal to \[\>=\] 5 years, adults; 3 items - toddlers \[aged 2-4 years\]). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Generic Core Scale total score: sum of all the items divided by the number of items answered across all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
time frame
Baseline and Month 4
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline patient-reported outcome (PRO) assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4

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-osteosarcoma
nct id
NCT04154189
qol key
qol-0010
source section id
NCT04154189-om-0010
source outcome index
10
instrument
Unnamed quality-of-life measure
instrument basis
matched 'hrqol' in the study's own wording
scale title
Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4
measure definition
HRQoL: PedsQL 3.0 Cancer Module Scale measured pediatric cancer-specific HRQoL. It included assessment of 8 dimensions: pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (3 items - toddlers \[aged 2-4\], 4 items - young children \[aged 5-7\]; 5 items for children aged \>=8 years, adults), perceived physical appearance (3 items), communication (3 items). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Cancer Module total score: sum of all items divided by the number of items answered on all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
time frame
Baseline and Month 4
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline PRO assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
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-osteosarcoma
nct id
NCT04154189
trial label
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcom
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.
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
3
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0000
    source section id
    NCT04154189-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS) by Independent Imaging Review (IIR) Assessment
    endpoint definition
    PFS as assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of PD or date of death (whichever occurred first), as determined using RECIST v1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.
    time origin
    From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first (up to 20.5 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all randomized participants regardless of the treatment actually received.
    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-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0001
    source section id
    NCT04154189-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants With PFS at Month 4 (PFS-4m Rate) by IIR Assessment
    endpoint definition
    PFS rate at 4 months as assessed by IIR was defined as the percentage of participants who were alive and without PD at 4 months from the randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. The PFS-4m was estimated using the Kaplan-Meier method.
    time origin
    Month 4
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all randomized participants regardless of the treatment actually received.
    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-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0002
    source section id
    NCT04154189-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With PFS at 1 Year or Month 12 (PFS-1y Rate) by IIR Assessment
    endpoint definition
    PFS-1y rate as assessed by IIR was defined as the percentage of participants who were alive and without PD at 1 year from randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS-1y rate was estimated using Kaplan-Meier method.
    time origin
    Month 12 or 1 Year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all randomized participants regardless of the treatment actually received.
    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-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0003
    source section id
    NCT04154189-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS was defined as the time from the date of randomization to the date of death from any cause. The median OS was from Kaplan-Meier product-limit estimates and 2-sided 95% CIs from a generalized Brookmeyer and Crowley method.
    time origin
    From the date of randomization to the date of death from any cause (up to 37.1 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all randomized participants regardless of the treatment actually received.
    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-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0004
    source section id
    NCT04154189-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Overall Survival at 1 Year or Month 12 (OS-1y)
    endpoint definition
    OS-1y was defined as the time from the date of randomization to the date of death from any cause assessed up to 1 year. OS was calculated using the Kaplan-Meier method.
    time origin
    Month 12 or 1 Year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all randomized participants regardless of the treatment actually received.
    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-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0005
    source section id
    NCT04154189-om-0005
    source outcome index
    5
    endpoint
    Objective Response Rate at Month 4 (ORR-4m) by IIR Assessment
    endpoint definition
    ORR-4m was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined by IIR using RECIST v1.1 within the first 4 months. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 95% confidence interval (CI) of ORR was calculated using the method of Clopper and Pearson.
    time origin
    Month 4
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all randomized participants regardless of the treatment actually received.
    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-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
    regimen
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Treatment Arm B: Ifosfamide + Etoposide
    regimen
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
    regimen
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Treatment Arm B: Ifosfamide + Etoposide
    regimen
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
    regimen
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Treatment Arm B: Ifosfamide + Etoposide
    regimen
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
    regimen
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Treatment Arm B: Ifosfamide + Etoposide
    regimen
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
    regimen
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Treatment Arm B: Ifosfamide + Etoposide
    regimen
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
    regimen
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Treatment Arm B: Ifosfamide + Etoposide
    regimen
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04154189-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma
    nct id
    NCT04154189
    harm key
    EG000
    source section id
    NCT04154189-ae
    event group key
    EG000
    event group label
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
    serious affected
    30
    serious at risk
    39
    other affected
    38
    other at risk
    39
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
    event definition
    Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
    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-osteosarcoma
    nct id
    NCT04154189
    harm key
    EG001
    source section id
    NCT04154189-ae
    event group key
    EG001
    event group label
    Treatment Arm B: Ifosfamide + Etoposide
    serious affected
    20
    serious at risk
    39
    other affected
    39
    other at risk
    39
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
    event definition
    Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
    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-osteosarcoma
    nct id
    NCT04154189
    harm key
    EG002
    source section id
    NCT04154189-ae
    event group key
    EG002
    event group label
    Treatment Arm B: Ifosfamide+Etoposide to Lenvatinib (Optional)
    serious affected
    10
    serious at risk
    16
    other affected
    16
    other at risk
    16
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
    event definition
    Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
    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-osteosarcoma
    nct id
    NCT04154189
    qol key
    qol-0009
    source section id
    NCT04154189-om-0009
    source outcome index
    9
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scale: Generic Core Scale Score at Month 4
    measure definition
    Health-Related Quality of Life (HRQoL): PedsQL 4.0 Generic Core Scale is a multidimensional scale. It included assessment of 4 dimensions: physical functioning (8 items), emotional functioning (8 items), social functioning (8 items), and school functioning (5 items - children greater than or equal to \[\>=\] 5 years, adults; 3 items - toddlers \[aged 2-4 years\]). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Generic Core Scale total score: sum of all the items divided by the number of items answered across all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
    time frame
    Baseline and Month 4
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline patient-reported outcome (PRO) assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
    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-osteosarcoma
    nct id
    NCT04154189
    qol key
    qol-0010
    source section id
    NCT04154189-om-0010
    source outcome index
    10
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'hrqol' in the study's own wording
    scale title
    Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4
    measure definition
    HRQoL: PedsQL 3.0 Cancer Module Scale measured pediatric cancer-specific HRQoL. It included assessment of 8 dimensions: pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (3 items - toddlers \[aged 2-4\], 4 items - young children \[aged 5-7\]; 5 items for children aged \>=8 years, adults), perceived physical appearance (3 items), communication (3 items). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Cancer Module total score: sum of all items divided by the number of items answered on all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL.
    time frame
    Baseline and Month 4
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    HRQoL Analysis Set included all participants who had received at least 1 dose of study drug and had completed at least 1 postbaseline PRO assessment. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
    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