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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT00334867
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically and cytologically confirmed extracranial Ewing's sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue
* Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural-based secondary tumor nodules allowed
* Contralateral pleural effusions or pleural nodules are not eligible
* Tumor arising in the bony skull (extradural) are eligible
* Tumors arising in the intradural soft tissue are not eligible
* Newly diagnosed disease
* Only have had a biopsy of the primary tumor without an attempt at complete or partial resection
* Prior attempted or accomplished unplanned excision allowed provided adequate imaging was obtained prior to surgery AND resection considered incomplete and further local control required
* No evidence of metastatic disease, defined as lesions discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor
* No evidence of metastatic lung disease by CT scan
* One pulmonary nodule \> 1 cm in diameter OR \> 1 nodule \> 0.5 cm in diameter are considered evidence of pulmonary metastasis
* Solitary nodules 0.5-1.0 cm or multiple nodules 0.3-0.5 cm must be confirmed negative by biopsy
* Solitary nodules \< 0.5 cm or multiple nodules \< 0.3 cm not considered clear evidence of lung disease
* No distant nodule disease
* No esthesioneuroblastoma
PATIENT CHARACTERISTICS:
* Performance status (PS) 0-2 (Karnofsky PS 50-100% for patients ≥ 16 years of age or Lansky PS 50-100% for patients \< 16 years of age)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT \< 2.5 times ULN
* Shortening fraction ≥ 27% by EKG
* Ejection fraction ≥ 50% by radionuclide angiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy
* No prior chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
50 Years
Study:
NCT00334867
Study Brief:
Protocol Section:
NCT00334867