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:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00645632
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed osteosarcoma of the extremity
* High-grade (grade III or IV) disease
* No low-grade disease (e.g., parosteal or periosteal osteosarcoma)
* No secondary osteosarcoma (i.e., tumor occurring in a radiotherapy field designed for a prior tumor)
* No Paget's disease
* No known metastases
PATIENT CHARACTERISTICS:
* Total bilirubin \< 2 times normal
* AST \< 2 times normal
* Alkaline phosphatase \< 2 times normal
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min
* LVEF ≥ 45%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy except retinoblastoma
* Patients with familial retinoblastoma syndrome who develop osteosarcoma unrelated to radiotherapy (e.g., in a primary site in the extremities) are eligible
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy
* Patients with retinoblastoma may have received radiotherapy to the orbits
* At least 28 days since prior initial amputation
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00645632
Study Brief:
Protocol Section:
NCT00645632