Clinical Trial Details
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NCT01231906 : Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
PhasePhase 3
AgesMin: N/A Max: 50 Years

- Newly diagnosed extracranial, non-metastatic Ewing sarcoma or primitive
neuroectodermal tumors of bone or soft tissue

- For the purpose of this study, any of the following are considered localized

- Chest wall tumors with ipsilateral pleural effusions

- Ipsilateral positive pleural fluid cytology

- Ipsilateral pleural-based secondary tumor nodules

- Regional node involvement, based on clinical suspicion confirmed by pathologic
documentation, are considered to be non-metastatic disease

- Tumors arising in the bony skull (extra-dural) are considered to be extracranial

- No evidence of metastatic disease, including the following:

- Lesions that are discontinuous from the primary tumor, are not regional lymph
nodes, and do not share a body cavity with the primary tumor

- Contralateral pleural effusion and contralateral pleural nodules

- Distant lymph node involvement

- Pulmonary nodules that meet the following criteria:

- Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied
and negative for Ewing sarcoma

- Biopsies of solitary nodule < 0.5 cm or multiple nodules < 3.0 cm (are not
required but if performed) positive for metastatic disease

- No tumors arising in the intra-dural soft tissue


- Creatinine clearance or radioisotope GFR ? 70 mL/min OR serum creatinine based on age
and/or gender as follows:

- 0.4 mg/dL (1 month to < 6 months of age)

- 0.5 mg/dL (6 months to < 1 year of age)

- 0.6 mg/dL (1 year to < 2 years of age)

- 0.8 mg/dL (2 years to < 6 years of age)

- 1.0 mg/dL (6 years to < 10 years of age)

- 1.2 mg/dL (10 years to < 13 years of age)

- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age)

- 1.7 mg/dL (male) or 1.4 mg/dL (female) (? 16 years of age)

- Total bilirubin < 1.5 times upper limit of normal (ULN)

- AST or ALT < 2.5 times ULN

- Shortening fraction of ? 27% by echocardiogram OR ejection fraction ? 50% by
radionuclide angiogram

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for the duration of study treatment


- No prior chemotherapy or radiotherapy

- Prior biopsy of the primary tumor without an attempt at complete or partial resection

- Patients are still allowed if unplanned excision was attempted or accomplished
as long as adequate imaging was obtained prior to surgery

- No other concurrent chemotherapy or immunomodulating agents (including steroids
unless used as an antiemetic)

- No concurrent sargramostim (GM-CSF)
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