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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT01586104

Collaborator

Northwestern University (Other), National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: intensity-modulated radiation therapy	N/A

Detailed Description

OBJECTIVES:

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.
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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (IMRT) Patients undergo cardiac-sparing whole lung IMRT.	Radiation: intensity-modulated radiation therapy Undergo cardiac-sparing whole lung IMRT Other Names: IMRT

Arm

Intervention/Treatment

Experimental: Treatment (IMRT)

Patients undergo cardiac-sparing whole lung IMRT.

Radiation: intensity-modulated radiation therapy

Undergo cardiac-sparing whole lung IMRT

Other Names:

IMRT

Outcome Measures

Primary Outcome Measures

Feasibility of delivering cardiac-sparing IMRT with central quality control in 20 subjects [1-5 years]
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.
Dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation [1-5 years]
Compare treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc.
Short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT [Estimated using Kaplan-Meier survival curves (six months after IMRT)]
At a minimum period of six months after IMRT

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 29 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Healthcare of Atlanta - Egleston	Atlanta	Georgia	United States	30322
2	Ann & Rober H Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
3	Riley Hospital for Children	Indianapolis	Indiana	United States	46202-5225
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224
7	M D Anderson Cancer Center	Houston	Texas	United States	77030