A Phase 3 Randomized Controlled Trial Comparing Open vs 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 for metastases,

with at least one of which being >= 3 mm and all of which must be =< 3 cm size.

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

- Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic

surgery. Determination of resectability is made by the institutional surgeon.

- Patients must have a histological diagnosis of osteosarcoma.

- Patients must have evidence of metastatic lung disease at the time of initial

diagnosis, or at time of 1st recurrence following completion of therapy for initially

localized disease.

- Patients with newly diagnosed disease must have completed successful gross tumor

resection for their primary tumor or surgical local control of primary tumor must be

planned 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 for

newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug

regimens) at the time of enrollment on this study. Dose and drug modifications for

toxicity do not exclude patients from participation.

- Patients at time of 1st recurrence must have completed systemic therapy for their

initial primary tumor, considered by the treating physician to be standard treatment

for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug

regimens) at the time of enrollment on this study. Dose and drug modifications for

toxicity 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., central

lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to

segmental bronchi).

- Patients with chest wall or mediastinal based metastatic lesions, or with significant

pleural effusion.

- Patients with disease progression at either the primary or pulmonary metastatic site

while on initial therapy. Note: Once the patient has been enrolled on the study,

additional computed tomography (CT) scans are not anticipated prior to thoracic

surgery. Note: Some variation in nodule size measurements over the course of

pre-operative therapy is anticipated and does not qualify for exclusion unless deemed

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 to

enrollment.

- All patients and/or their parents or legal guardians must sign a written informed

consent.

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute

(NCI) requirements for human studies must be met.