Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Inclusion Criteria:

• Patients must be < 50 years at the time of enrollment.

• Patients must have =< 4 nodules per lung consistent with or suspicious formetastases, with at least one of which being >= 3 mm and all of which must be =< 3cm size.

• Note: Patient must have eligibility confirmed by rapid central imaging review.

• Lung nodules must be considered resectable by either open thoracotomy orthoracoscopic surgery. Determination of resectability is made by the institutionalsurgeon.

• Patients must have a histological diagnosis of osteosarcoma.

• Patients must have evidence of metastatic lung disease at the time of initialdiagnosis, or at time of 1st recurrence following completion of therapy forinitially localized disease.

• Patients with newly diagnosed disease must have completed successful gross tumorresection for their primary tumor or surgical local control of primary tumor must beplanned to be performed simultaneously with thoracic surgery.

• Newly diagnosed patients must be receiving or recently completed (within 60 days)systemic therapy considered by the treating physician to be standard treatment fornewly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drugregimens) at the time of enrollment on this study. Dose and drug modifications fortoxicity do not exclude patients from participation.

• Patients at time of 1st recurrence must have completed systemic therapy for theirinitial primary tumor, considered by the treating physician to be standard treatmentfor newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drugregimens) at the time of enrollment on this study. Dose and drug modifications fortoxicity do not exclude patients from participation.

Exclusion Criteria:

• Patients with unresectable primary tumor.

• Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., centrallesion involves or is proximal to segmental bronchi and peripheral is lesion distalto segmental bronchi).

• Patients with chest wall or mediastinal based metastatic lesions, or withsignificant pleural effusion.

• Patients with disease progression at either the primary or pulmonary metastatic sitewhile on initial therapy. Note: Once the patient has been enrolled on the study,additional computed tomography (CT) scans are not anticipated prior to thoracicsurgery. Note: Some variation in nodule size measurements over the course ofpre-operative therapy is anticipated and does not qualify for exclusion unlessdeemed true disease progression by the primary treatment team.

• Patients with evidence of extrapulmonary metastatic disease.

• Patients who received therapeutic pulmonary surgery for lung metastasis prior toenrollment.

• All patients and/or their parents or legal guardians must sign a written informedconsent.

• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.