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CompletedNCT01586104Updated Feb 10, 2025Results posted

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

An interventional study of intensity-modulated radiation therapy in Adult Rhabdomyosarcoma, Lung Metastases and Metastatic Ewing Sarcoma, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 7 sites in United States. Open to participants aged 1 Year to 29 Years. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Feb 2011, registered Apr 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 29 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adult Rhabdomyosarcoma
  • Lung Metastases
  • Metastatic Ewing Sarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Wilms Tumor and Other Childhood Kidney Tumors
  • Stage IV Adult Soft Tissue Sarcoma
  • Stage IV Wilms Tumor
  • Stage V Wilms Tumor
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's enrollment of 20 is below the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Treatment (IMRT)

    Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).

    Radiation: intensity-modulated radiation therapy

Interventions

  • Radiationintensity-modulated radiation therapy

    Undergo cardiac-sparing whole lung IMRT

    Also known as: IMRT

06

What researchers measure

Primary outcomes

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

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

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

    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. Mean Percentage Radiation Dose to Organ Volumes

    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 frame: This outcome is measured from central review of radiation plans within 1-2 days of receipt.

07

Results

Posted Feb 10, 2025

Participant flow

Participant flow — Overall Study
MilestoneTreatment (IMRT)
Started20
Completed20
Not completed0

Outcome measures

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

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 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.
Reported as:
Count of participants · Participants
Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects
ParticipantsTreatment (IMRT)
Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects20
PrimaryShort-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)

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

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.
Reported as:
Count of participants · Participants
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
ParticipantsTreatment (IMRT)
2yr overall survival18
3yr overall survival18
2yr lung-metastasis progression free survival13
3yr lung-metastasis progression free survival10
Pulmonary relapse8
Pulmonary relapse - after primary therapy4
Pulmonary relapse - after relapse/progression4
Deceased from progressive disease2
SecondaryMean Percentage Radiation Dose to Organ Volumes

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 frame:
This outcome is measured from central review of radiation plans within 1-2 days of receipt.
Reported as:
Mean · Mean % radiation dose to % organ volume
Mean Percentage Radiation Dose to Organ Volumes
Mean % radiation dose to % organ volumeTreatment (IMRT)
Heart - V50 (%) for IMRT96 ± 5.4
Heart - V50 (%) for AP- PA100 ± 0.8
Heart - V83 (%) for IMRT65 ± 12.1
Heart - V83 (%) for AP-PA100 ± 2.2
Heart - V95 (%) for IMRT39 ± 15.5
Heart- V95 (%) for AP-PA97 ± 6.7
Left Ventricle - V50 (%) for IMRT95 ± 7.8
Left Ventricle - V50 (%) for AP-PA100 ± 0
Left Ventricle - V95 (%) for IMRT33 ± 15.9
Left Ventricle - V95 (%) for AP-PA99 ± 2.7
Right Ventricle - V50 (%) for IMRT91 ± 9.8
Right Ventricle - V50 (%) for AP-PA100 ± 1.6
Right Ventricle - V83 (%) for IMRT42 ± 12.7
Right Ventricle - V83 (%) for AP-PA99 ± 4
Right Ventricle - V95 (%) for IMRT18 ± 8.9
Right Ventricle - V95 (%) for AP-PA97 ± 8.2
Right Atrium - V50 (%) for IMRT99 ± 0.4
Right Atrium - V50 (%) for AP-PA99 ± 0.7
Right Atrium - V95 (%) for IMRT57 ± 22.5
Right Atrium - V95 (%) for AP-PA97 ± 11.1
Left Atrium V50 (%) for IMRT99 ± 0.4
Left Atrium V50 (%) for AP-PA100 ± 0.2
Left Atrium - V95 (%) for IMRT55 ± 22.3
Left Atrium - V95 (%) for AP-PA94 ± 15.4
Right Coronary Artery - V95 (%) for IMRT100 ± 0
Right Coronary Artery - V95 (%) for AP-PA100 ± 0
Left Coronary Artery - V95 (%) for IMRT88 ± 9.9
Left Coronary Artery - V95 (%) for AP-PA99 ± 1.3
Myocardium - V50 (%) for IMRT94 ± 8
Myocardium - V50 (%) for AP-PA100 ± 0
Myocardium - V95 (%) for IMRT69 ± 7.56
Myocardium - V95 (%) for AP-PA99 ± 0.88
Thyroid - V50 (%) for IMRT44 ± 32.5
Thyroid - V50 (%) for AP-PA33 ± 31.3
Kidneys - V50 (%) for IMRT5 ± 7.6
Kidneys - V50 (%) for AP-PA6 ± 6.8
Stomach - V50 (%) for IMRT62 ± 21.7
Stomach - V50 (%) for AP-PA62 ± 24.5
Liver - V50 (%) for IMRT55 ± 11.4
Liver - V50 (%) for AP-PA54 ± 11.4
Statistical analysis
  • Treatment (IMRT) · Bonferroni corrected at p<0.0125 · p = <0.0125 (The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (IMRT)2/20 (10%)2/20 (10%)0/20 (0%)
Most frequent serious events
Most frequent serious events
EventTreatment (IMRT)
Deceased from progressive disease.General disorders2/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (IMRT)
Mean13 (1 to 25)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (IMRT)
Female9
Male11
Region of Enrollment
Region of Enrollment(Participants)Treatment (IMRT)
United States20
08

Study locations

7 sites
  • Children's Healthcare of Atlanta - Egleston
    Atlanta, Georgia 30322, United States
  • Ann & Rober H Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46202-5225, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01586104
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Northwestern University, National Cancer Institute (NCI)
Responsible party
John Kalapurakal (Attending Physician, Ann & Robert H Lurie Children's Hospital of Chicago) — Principal investigator
First posted
Apr 26, 2012
Start date
Feb 2011
Primary completion
Jun 2, 2016
Completion
Jun 2, 2016
Results posted
Feb 10, 2025
Last update
Feb 10, 2025

Study contacts

David Walterhouse
principal investigator · Ann & Robert H Lurie Children's Hospital of Chicago

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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