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

Primary Purpose

Adult Rhabdomyosarcoma, Lung Metastases, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intensity-modulated radiation therapy
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Rhabdomyosarcoma

Eligibility Criteria

1 Year - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Healthcare of Atlanta - Egleston
  • Ann & Rober H Lurie Children's Hospital of Chicago
  • Riley Hospital for Children
  • Dana-Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Children's Hospital of Pittsburgh of UPMC
  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (IMRT)

Arm Description

Patients undergo cardiac-sparing whole lung IMRT.

Outcomes

Primary Outcome Measures

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.
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.
Short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT
At a minimum period of six months after IMRT

Secondary Outcome Measures

Full Information

First Posted
April 23, 2012
Last Updated
September 23, 2013
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Northwestern University, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01586104
Brief Title
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
Official Title
Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2015 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Northwestern University, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (IMRT)
Arm Type
Experimental
Arm Description
Patients undergo cardiac-sparing whole lung IMRT.
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Undergo cardiac-sparing whole lung IMRT
Primary Outcome Measure Information:
Title
Feasibility of delivering cardiac-sparing IMRT with central quality control in 20 subjects
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.
Time Frame
1-5 years
Title
Dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation
Description
Compare treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc.
Time Frame
1-5 years
Title
Short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT
Description
At a minimum period of six months after IMRT
Time Frame
Estimated using Kaplan-Meier survival curves (six months after IMRT)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ann & Rober H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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