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NCT01586104 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2025-02-10

This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects

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outcome · POSTED

Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)

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outcome · POSTED

Mean Percentage Radiation Dose to Organ Volumes

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients may have a Wilms tumor, Ewing Sarcoma, Rhabdomyosarcoma or any other metastatic pediatric malignancy; patients may have a single or multiple pulmonary metastases at the time of diagnosis or at the time of recurrence; a pulmonary metastasis may be defined as one pulmonary nodule \>= 1 cm or more than one pulmonary nodules \>= 0.5 cm; a biopsy of the nodules may be considered in case of doubt * The Karnofsky performance status must be \>= 50 for patients \> 16 years of age and the Lansky performance status must be \>= 50 for patients =\< 16 years of age * Patients must not have received prior radiation therapy to any part of the thorax * Adequate cardiac function defined as: * Shortening fraction of \>= 27% by echocardiogram, or * Ejection fraction of \>= 50% by radionuclide angiogram * Female patients of childbearing age must have a negative pregnancy test * Female patients who are lactating must agree to stop breast-feeding * Sexually active patients of childbearing potential must agree to use effective contraception Exclusion Criteria: * Patients enrolled on Children's Oncology Group protocols cannot be treated with whole lung IMRT on this study * Patients who have a prior history of radiation therapy to the thorax or adjacent regions cannot be entered on this protocol * Patient with Hodgkin's Lymphoma are not eligible for this study * Patients with mediastinal masses or other pulmonary masses requiring additional mediastinal or lung irradiation beyond the whole lung irradiation (WLI) doses stated in this protocol are ineligible for this study * Patients who may require concurrent or sequential irradiation to sites beyond the chest such as the neck, flank, abdomen or liver are eligible for this study
healthy Volunteers
false
maximum Age
29 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).
    intervention Names
    1. Radiation: intensity-modulated radiation therapy
    label
    Treatment (IMRT)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (IMRT)
    description
    Undergo cardiac-sparing whole lung IMRT
    name
    intensity-modulated radiation therapy
    other Names
    1. IMRT
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects
    time Frame
    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.
  2. description
    Serial CT scans of the chest were examined to determine lung-metastasis free survival
    measure
    Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
    time Frame
    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.
secondary Outcomes
  1. description
    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
    measure
    Mean Percentage Radiation Dose to Organ Volumes
    time Frame
    This outcome is measured from central review of radiation plans within 1-2 days of receipt.
Full study description
brief Summary
This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
detailed Description
OBJECTIVES: I. To demonstrate the feasibility of delivering cardiac-sparing IMRT in a multi-institutional setting with central quality control for children and young adults with metastatic tumors in the lungs. II. To prospectively determine the dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation by comparing treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc. in all patients enrolled in this study. III. To determine the short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT at a minimum period of six months after IMRT. OUTLINE: Patients undergo cardiac-sparing whole lung IMRT. After completion of study treatment, patients are followed up for 1-5 years.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice