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

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Childhood Solid Tumor, Protocol Specific; Unspecified Adult Solid Tumor, Protocol Specific; Lung Metastases; Recurrent Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Adult Rhabdomyosarcoma; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Stage IV Wilms Tumor; Stage V Wilms Tumor
• Intervention / Treatment: Radiation: intensity-modulated radiation therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta - Egleston
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Rober H Lurie Children's Hospital of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5225
      • Riley Hospital for Children
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 29 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Cancer Institute (NCI); Northwestern University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion: September 1, 2015

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neoplasms, Glandular and Epithelial; Disease Attributes; Genetic Diseases, Inborn; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms, Neuroepithelial; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Neoplastic Processes; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Myosarcoma; Sarcoma; Lung Neoplasms; Neoplasm Metastasis; Recurrence; Sarcoma, Ewing; Rhabdomyosarcoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Wilms Tumor; Neuroectodermal Tumors, Primitive, Peripheral; Rhabdomyosarcoma, Embryonal
• Other Study ID Numbers: Lung IMRT