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

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Completed

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Stage IV Adult Soft Tissue Sarcoma

Metastatic Ewing Sarcoma

Recurrent Wilms Tumor and Other Childhood Kidney Tumors

Lung Metastases

Stage IV Wilms Tumor

Recurrent Adult Soft Tissue Sarcoma

Stage V Wilms Tumor

Adult Rhabdomyosarcoma

Previously Treated Childhood Rhabdomyosarcoma

Unspecified Childhood Solid Tumor, Protocol Specific

Recurrent Childhood Rhabdomyosarcoma

Treatments

Radiation: intensity-modulated radiation therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01586104

Lung IMRT

R21CA159547 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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.

Enrollment

20 patients

Sex

All

Ages

1 to 29 years old

Volunteers

No Healthy Volunteers

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