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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adult Rhabdomyosarcoma, Lung Metastases, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, 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

Intervention / Treatment
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* Radiation: intensity-modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (IMRT)<br>Patients undergo cardiac-sparing whole lung IMRT. | Radiation: intensity-modulated radiation therapy<br>* Undergo cardiac-sparing whole lung IMRT<br>* Other names: IMRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of delivering cardiac-sparing IMRT with central quality control in 20 subjects | Feasibility of delivering whole lung IMRT will be demonstrated by obtaining QARC central quality control approval of institutional IMRT plans for the 20 subjects enrolled onto the study. | 1-5 years | 
| Dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation | Compare treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc. | 1-5 years | 
| Short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT | At a minimum period of six months after IMRT | Estimated using Kaplan-Meier survival curves (six months after IMRT) |