Kidney Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Kidney Cancer

Estimated Enrollment:

20

Study ID:

NCT01586104

Recruitment Status:

Completed

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

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There are 7 Locations for this study

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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, 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

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Estimated Enrollment:

20

Study ID:

NCT01586104

Recruitment Status:

Completed

Sponsor:


Ann & Robert H Lurie Children's Hospital of Chicago

How clear is this clinincal trial information?

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