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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-06-02

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.

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (IMRT)

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

Group Type EXPERIMENTAL

intensity-modulated radiation therapy

Intervention Type RADIATION

Undergo cardiac-sparing whole lung IMRT

Interventions

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intensity-modulated radiation therapy

Undergo cardiac-sparing whole lung IMRT

Intervention Type RADIATION

Other Intervention Names

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IMRT

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No