Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study
Verified date | September 2013 |
Source | Ann & Robert H Lurie Children's Hospital of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2015 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 29 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Ann & Rober H Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago | National Cancer Institute (NCI), Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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) |
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