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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT00662233
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of any of the following:
* High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas (excluding undifferentiated sarcoma and Ewing sarcoma)
* Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft tissue) (closed to accrual)
* Undifferentiated sarcomas (closed to accrual)
* Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I paratesticular) (closed to accrual)
* All alveolar rhabdomyosarcomas (closed to accrual)
* No evidence distant metastatic disease (i.e., lung, bone, bone marrow)
* Local or regional nodal disease allowed
* No spindle cell tumors of bone
* Primary lesions do not have to be resectable
PATIENT CHARACTERISTICS:
* Creatinine ≤1.5 mg/dL OR creatinine clearance \> 60 mL/min/
* AST/ALT \< 2 times upper limit of normal (ULN)
* Total bilirubin \< 2 times ULN
* LVEF ≥ 45%
* No prior history of cancer
* Not pregnant or nursing
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
* Patients who have undergone radiation therapy after initial surgery are eligible but must have evaluation for metastatic disease within 2 weeks of starting chemotherapy
* No prior chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00662233
Study Brief:
Protocol Section:
NCT00662233