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

This study has been completed.
Sponsor:
Collaborators:
Northwestern University
Information provided by (Responsible Party):
David O Walterhouse, MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01586104
First received: April 23, 2012
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Feasibility of delivering cardiac-sparing IMRT with central quality control in 20 subjects [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Estimated using Kaplan-Meier survival curves (six months after IMRT) ] [ Designated as safety issue: No ]
    At a minimum period of six months after IMRT


Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (IMRT)
Patients undergo cardiac-sparing whole lung IMRT.
Radiation: intensity-modulated radiation therapy
Undergo cardiac-sparing whole lung IMRT
Other Name: IMRT

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.

  Eligibility

Ages Eligible for Study:   1 Year to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586104

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

No publications provided

Responsible Party: David O Walterhouse, MD, Attending Physician, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01586104     History of Changes
Other Study ID Numbers: Lung IMRT
Study First Received: April 23, 2012
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Sarcoma, Ewing
Sarcoma
Neoplasm Metastasis
Neoplasms
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Wilms Tumor
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Lung Neoplasms
Kidney Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Complex and Mixed
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal

ClinicalTrials.gov processed this record on October 01, 2014