Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT01586104
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
29 Years
Study:
NCT01586104
Study Brief:
Protocol Section:
NCT01586104