Osteosarcoma Study #2: A Randomized Trial of Pre-Surgical Chemotherapy vs. Immediate Surgery and Adjuvant Chemotherapy in the Treatment of Non-Metastatic Osteosarcoma. A Pediatric Oncology Group Phase III Study
Osteosarcoma
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring Non-Metastatic Osteosarcoma, Presurgical Chemotherapy
Eligibility Criteria
Must be less than or equal to 30 years of age. No prior history of cancer. No prior therapy-other than biopsy. Informed consent according or institutional guidelines (Agreement to randomization to either presurgical chemotherapy or immediate surgery-physicians must also agree). Less than or equal to 21 days since initial diagnosis and eligible to have surgery within 3 weeks of randomization. Must have a high grade osteosarcoma. Must not have low grade osteosarcoma, periosteal and parosteal osteosarcoma, or multi-focal sclerosing of osteosarcoma. Tumor must be confined to extremity or expendable and resectable bone of axial skeleton (i.e., ilium, scapula, clavicle, rib). No evidence of metastases by PE, CXR, chest CT, and bone scans. (Chest CT must be normal within 2 weeks of randomization). Abnormalities on chest CT must be biopsy-negative or thoracotomy negative. Suspicious lesions on bone scan should be biopsied. LDH level and surgical intent (i.e., amputation, resection, or limb replacement) must be known before patient is registered.
Sites / Locations
- National Cancer Institute (NCI)