IRB Study Number 23-008
Status Recruiting
Institute Taussig Cancer Institute
Description
1.1 Primary Objective
1.1.1 To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
1.2 Secondary Objectives
1.2.1 To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
1.2.2 To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma.
1.2.3 To determine if thoracoscopy is superior to open surgical resection for post-operative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.
Inclusion Criteria
3.2.1 Age
Patients must be < 50 years at the time of enrollment.
3.2.2 Diagnosis
3.2.2.1 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 (see Section 16.4.2).
Note: Patient must have eligibility confirmed by rapid central imaging review (see Section 16.2):
3.2.2.2 Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
3.2.2.3 Patients must have a histological diagnosis of osteosarcoma.
3.2.2.4 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.
3.2.2.5 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.
A series of clinical scenario examples are provided in Appendix III to assist investigators in their consideration of patient eligibility.
3.2.3 Prior Therapy
3.2.3.1 Newly diagnosed patients must be receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
3.2.3.2 Patients at time of 1st recurrence must have previously completed initial systemic therapy for their primary tumor, considered by the treating physician as at least equivalent to MAP.
Please see Section 4.1 for the concomitant therapy restrictions for patients during treatment.
Exclusion Criteria
3.2.4 Patients with unresectable primary tumor.
3.2.5 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).
3.2.6 Patients with pleural or mediastinal based metastatic lesions, or with pleural effusion.
3.2.7 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 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.
3.2.8 Patients with evidence of extrapulmonary metastatic disease.
3.2.9 Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
3.2.10 Regulatory Requirements
3.2.10.1 All patients and/or their parents or legal guardians must sign a written informed consent.
3.2.10.2 All institutional, FDA, and NCI requirements for human studies must be met.
