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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586104
• Other study ID #: Lung IMRT
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: September 23, 2013
• Start date: February 2011
• Est. completion date: September 2015

Study information

• Verified date: September 2013
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Rhabdomyosarcoma
• Kidney Neoplasms
• Lung Metastases
• Lung Neoplasms
• Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Neoplasm Metastasis
• Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Neuroectodermal Tumors, Primitive, Peripheral
• 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
• Rhabdomyosarcoma
• Sarcoma
• Sarcoma, Ewing
• 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
• Wilms Tumor

Intervention

Radiation:
• intensity-modulated radiation therapy
Undergo cardiac-sparing whole lung IMRT

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Egleston	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Ann & Rober H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	M D Anderson Cancer Center	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Cancer Institute (NCI), Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)