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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01258634
Eligibility Criteria:
Inclusion Criteria:
* Must be between 2 and 35 years of age at time of diagnosis
* Must have biopsy-proven, high-grade osteosarcoma.
* Patients with metastases are eligible as long as the lung is the only site of metastatic disease.
* The primary tumor and all pulmonary metastases must be deemed to be potentially resectable. There must be a commitment by the surgical team to resect the primary tumor at week 12, and pulmonary nodules at any point, unless the clinical situation indicates these interventions are not in the patient's best interest.
* Patients must have normal laboratory values and cardiac function as defined below:
* Creatinine clearance or radioisotope GFR of \> or equal to 70ml/min/1.73 m2 OR
A serum creatinine based on age/gender as follows:
Age Maximum Serum Creatinine (mg/dL) Male Female
1 month to \< 6 months 0.4 0.4 6 months to \< 1 year 0.5 0.5
1. to \< 2 years 0.6 0.6
2. to \< 6 years 0.8 0.8
6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
* or equal to 16 years 1.7 1.4
* Cardiac: Adequate cardiac function is defined as:
Shortening fraction of \> or equal to 28% by echocardiogram OR Ejection fraction of \> or equal to 50% by radionuclide angiogram
* Hepatic: Adequate liver function is described as:
Total bilirubin of \< or equal to 1.5 x upper limit of normal (ULN) for age
* Hematologic function: adequate hematologic function is defined as:
ANC \> or equal to 1.5 x 10\^9/L and platelet count \> or equal to 100 x 10\^9/L
* Female patients must have a negative pregnancy test
* Female patients who are lactating must agree to stop breast-feeding.
* Patients must not be known to be HIV positive. Testing for HIV is not mandatory.
* Sexually active patients of childbearing potential must agree to use effective contraception.
* Patients must be able to cooperate fully with all planned protocol therapy.
* Signed informed consent MUST be obtained from patient or parent/legal guardian prior to any study procedures and study entry.
Exclusion Criteria:
* Patients with any low-grade osteosarcoma, post-radiation osteosarcoma, and osteosarcoma associated with Paget's disease are not eligible.
* Patients with metastases other than lung metastases are not eligible.
* Patients may not have received prior chemotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
35 Years
Study:
NCT01258634
Study Brief:
Protocol Section:
NCT01258634