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

April 23, 2012
September 23, 2013
February 2011
September 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01586104 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Undergo cardiac-sparing whole lung IMRT
Other Name: IMRT
Experimental: Treatment (IMRT)
Patients undergo cardiac-sparing whole lung IMRT.
Intervention: Radiation: intensity-modulated radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2015
September 2013   (final data collection date for primary outcome measure)

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
Both
1 Year to 29 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01586104
Lung IMRT
Yes
David O Walterhouse, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
  • Northwestern University
  • National Cancer Institute (NCI)
Not Provided
Ann & Robert H Lurie Children's Hospital of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP