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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT01231906
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:
* For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease
* Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic
* Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic
* Tumors arising in the bony skull (extra-dural) are considered to be extracranial
* Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist
* No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70mL/min/1.73 m\^2 or serum creatinine based on age/gender as follows:
* 1 month to \< 6 months: 0.4 mg/dL
* 6 months to \< 1 year: 0.5 mg/dL
* 1 to \< 2 years: 0.6 mg/dL
* 2 to \< 6 years: 0.8 mg/dL
* 6 to \< 10 years: 1 mg/dL
* 10 to \< 13 years: 1.2 mg/dL
* 13 to \< 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
* \>= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
* Total bilirubin \< 1.5 x upper limit of normal (ULN) for age
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age
* Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by radionuclide angiogram
Exclusion Criteria:
* Patients must have no evidence of metastatic disease; metastatic disease are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken
* Skeletal lesions in adjacent bones (trans-articular)
* Contralateral pleural effusion and contralateral pleural nodules
* Distant lymph node involvement
* Patients with pulmonary nodules are considered to have metastatic disease if the patient has:
* Solitary nodule \> 0.5 cm or multiple nodules of \> 0.3 cm unless biopsied and negative for Ewing's
* Biopsies of solitary nodule =\< 0.5 cm or multiple nodules =\< 0.3 cm are not required but if performed and positive indicate metastatic disease
* Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible
* Patients with pathologic diagnoses other than Ewing sarcoma will be excluded
* Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy
* Pregnant women will not be entered on this study; pregnancy tests must be obtained in female patients who are post-menarchal; lactating females may not participate unless they have agreed not to breastfeed their infants; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
50 Years
Study:
NCT01231906
Study Brief:
Protocol Section:
NCT01231906