Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
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Clinical Trial Information
Trial Contact: Parker, Melanie; Armatti, Julie M; Jones, Jamie; Singh, Sarah H; Frankos, Marie; Torrescano, Tanner
Trial Phone: 321-843-1036 ; 321-843-5284 ; 3218412008 ; 321.841.7561 ; 321-842-8738 ; 321-841-8271
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IRB No: C25.305.10
Protocol Abbrev: AOST2031
Principal Investigator: Jaime Libes, MD, MPH
Phase: Drug: Phase III
Age Group: Pediatric
Treatment: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Questionnaire Administration; Procedure: Thoracoscopy; Procedure: Thoracotomy
Therapies Involved: Surgery
ClinicalTrials.gov ID: NCT05235165
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Objective
To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
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Key Eligibility
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.
