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:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT00061893
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Newly diagnosed Ewing's sarcoma family of tumors of the bone or soft tissues
* Paraspinal tumors of extra-dural origin and Askin's tumor of the chest wall are eligible
* Metastatic disease, defined by the following criteria:
* Lesions are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor
* A single pulmonary or pleural nodule greater than 1 cm OR multiple nodules greater than 0.5 cm are considered evidence of pulmonary or pleural metastases (unless there is another clear medical explanation for these lesions)
* Contralateral pleural effusions are considered metastatic disease
* No CNS involvement
PATIENT CHARACTERISTICS:
Age
* 50 and under (at diagnosis)
Performance status
* Lansky 50-100% (under 17 years of age)
* Karnofsky 50-100% (age 17 and over)
* Patients whose performance status is affected by a pathological fracture are allowed provided they are able to undergo treatment
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST or ALT less than 5 times ULN
Renal
* Creatinine adjusted according to age as follows\*:
* No greater than 0.4 mg/dL (≤ 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over \[female\])
* No greater than 1.5 mg/dL (13 years to 15 years \[male\])
* No greater than 1.7 mg/dL (16 years and over \[male\]) OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min\* NOTE: \*Unless these values are related to renal insufficiency secondary to tumor involvement that is expected to improve once the tumor mass is smaller (e.g., pelvic mass causing obstructive hydronephrosis)
Cardiovascular
* Shortening fraction at least 27% by echocardiogram OR
* Ejection fraction at least 50% by MUGA
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Body surface area at least 0.4 m\^2
* No allergy to sulfa
* No aspirin hypersensitivity
* No asthma triad (asthma with nasal polyps, and urticaria)
* No other prior cancer, including nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior bone marrow or stem cell transplantation
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* Not specified
Other
* No other concurrent nonsteroidal anti-inflammatory medications, including salicylates
* No concurrent dexrazoxane unless approved by the study investigator
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
50 Years
Study:
NCT00061893
Study Brief:
Protocol Section:
NCT00061893