Upfront Surgical Resection for the Treatment of Localized High-Grade Osteosarcoma of the Extremity

Inclusion Criteria

• Patients must be at least 5 years of age and less than or equal to 40 years of age at enrollment
• Patients must have newly diagnosed, previously untreated localized high-grade osteosarcoma of an extremity verified by histopathology. Patients who underwent biopsy at another center will be eligible for protocol participation if they meet all other protocol eligibility criteria and have had their biopsy samples reviewed by the treating institution’s Department of Pathology. Patients must not require a custom implant necessitating design and manufacturing time. Plan must include adjuvant systemic chemotherapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin, and cisplatin (MAP) at the time of enrollment on this study
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age

Exclusion Criteria

• Patients with metastatic disease at diagnosis
• Initiation of systemic therapy prior to enrollment
• Prior history of cancer
• Prior radiation therapy
• Active life-threatening infection
• Pregnancy and breastfeeding * Female patients who are pregnant are ineligible * Lactating females are not eligible unless they have agreed not to breastfeed their infants * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
• Inability to comply with protocol requirements