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← recurrent Childhood Rhabdomyosarcoma

NCT01586104 · STUDY IN CONTEXT

Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Feasibility is defined as an enrolled patient receiving the IMRT treatment as stipulated in the protocol. Feasibility of delivering whole lung IMRT will be demonstrated by obtaining central (Quality Assurance Review Center 'QARC') quality control approval of enrolled patient treatment plans according to the protocol guidelines for the 20 subjects enrolled onto the study. If an enrolled patient did not receive the IMRT treatment as stipulated in the protocol this subject then the treatment will be considered not feasible in this patient.

14 patients had pediatric sarcomas; 5 had Wilms tumor; 1 had hepatoblastoma. 15/20 received RT to primary site. 15 had CS-IMRT as part of primary therapy vs 5 had CS-IMRT at relapse/progressive disease. At time of CS-IMRT, 18/20 patients' lung tumors were in remission/stable \& 2 had progressive disease.

→

primary · POSTED

Serial CT scans of the chest were examined to determine lung-metastasis free survival

Overall survival and incidence rates of additional relevant clinical data

→

secondary · POSTED

The IMRT and standard anteroposterior (AP-PA) treatment plans were reviewed and compared for target coverage and organ dose-volume histograms. The mean percentage volume of the organ or organ sub-region receiving a percentage of the dose was estimated from the computerized treatment plans for these two techniques were estimated and compared statistically

Source null

→

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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01586104
trial label
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
    nct id
    NCT01586104
    outcome key
    om-0000
    source section id
    NCT01586104-om-0000
    source outcome index
    0
    endpoint
    Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects
    endpoint definition
    Feasibility is defined as an enrolled patient receiving the IMRT treatment as stipulated in the protocol. Feasibility of delivering whole lung IMRT will be demonstrated by obtaining central (Quality Assurance Review Center 'QARC') quality control approval of enrolled patient treatment plans according to the protocol guidelines for the 20 subjects enrolled onto the study. If an enrolled patient did not receive the IMRT treatment as stipulated in the protocol this subject then the treatment will be considered not feasible in this patient.
    time origin
    All IMRT treatment plans were centrally reviewed within 1-2 days of receipt of the radiation therapy plan. The feasibility was determined as 'feasible' if deemed in accordance with protocol guidelines after central QARC review within 1-2 days of receipt.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    14 patients had pediatric sarcomas; 5 had Wilms tumor; 1 had hepatoblastoma. 15/20 received RT to primary site. 15 had CS-IMRT as part of primary therapy vs 5 had CS-IMRT at relapse/progressive disease. At time of CS-IMRT, 18/20 patients' lung tumors were in remission/stable \& 2 had progressive disease.
    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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
    nct id
    NCT01586104
    outcome key
    om-0001
    source section id
    NCT01586104-om-0001
    source outcome index
    1
    endpoint
    Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
    endpoint definition
    Serial CT scans of the chest were examined to determine lung-metastasis free survival
    time origin
    From date of enrollment until the date of first documented progression, relapse or date of death from any cause up to an average of 3 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Overall survival and incidence rates of additional relevant clinical data
    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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
    nct id
    NCT01586104
    outcome key
    om-0002
    source section id
    NCT01586104-om-0002
    source outcome index
    2
    endpoint
    Mean Percentage Radiation Dose to Organ Volumes
    endpoint definition
    The IMRT and standard anteroposterior (AP-PA) treatment plans were reviewed and compared for target coverage and organ dose-volume histograms. The mean percentage volume of the organ or organ sub-region receiving a percentage of the dose was estimated from the computerized treatment plans for these two techniques were estimated and compared statistically
    time origin
    This outcome is measured from central review of radiation plans within 1-2 days of receipt.
    analysis role
    secondary
    reporting status
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
    nct id
    NCT01586104
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (IMRT)
    regimen
    Patients had radiation therapy planning performed for cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT) according to stipulated guidelines in the protocol.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01586104-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
    nct id
    NCT01586104
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (IMRT)
    regimen
    Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01586104-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
    nct id
    NCT01586104
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (IMRT)
    regimen
    Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01586104-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
    nct id
    NCT01586104
    harm key
    EG000
    source section id
    NCT01586104-ae
    event group key
    EG000
    event group label
    Treatment (IMRT)
    serious affected
    2
    serious at risk
    20
    other affected
    0
    other at risk
    20
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    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