Clareo Health | A Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response
A Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Chicago
Age
2–35
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Patients may not have received prior chemotherapy.
