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



Status:Completed
Conditions:Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 29
Updated:10/14/2017
Start Date:February 2011
End Date:September 2015

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Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study

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.

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.

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
We found this trial at
7
sites
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Atlanta, GA
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, PA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, IL
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Houston, Texas 77030
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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