A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with OsteosarcomaAn Intergroup NCTN Phase 3 Study

Contact:

NCT Number:

Protocol:

AAAV0192

Study Status:

Active/Enrolling

Population:

Pediatrics/Adult

Phase:

III

This study will be the first randomized controlled trial of surgical approach for pulmonary metastatic osteosarcoma. The study will randomize surgical resection of pulmonary metastases between Open surgery (thoracotomy or sternotomy) and minimally invasive Thoracoscopy. Primary outcome will be thoracic event free survival (thoracic event is defined as intrathoracic tumor recurrence by chest CT or death that results from the procedure or a complication related to the procedure). Correlative outcomes include quality of life from patient-reported outcomes, along with imaging and laboratory studies.

Are you Eligible? (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 -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 >Patient must meet all eligibility criteria as outlined in the study protocol.

Specialty Area(s)

Acute Lymphocytic leukemia, Lymphoma, Non-Hodgkin's Lymphoma, Osteosarcoma

Principal Investigator

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  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant
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