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


N/A
1 Year
29 Years
Open (Enrolling)
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of delivering cardiac-sparing IMRT with central quality control in 20 subjects

Outcome Description:

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.

Outcome Time Frame:

1-5 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

Lung IMRT

NCT ID:

NCT01586104

Start Date:

February 2011

Completion Date:

Related Keywords:

  • 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
  • Kidney Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Wilms Tumor
  • Rhabdomyosarcoma
  • Lung Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Rhabdomyosarcoma, Embryonal
  • Sarcoma
  • Neoplasms
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral

Name

Location

Ann & Rober H Lurie Children's Hospital of ChicagoChicago, Illinois  60611