A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Children's Oncology Group
Summary
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
Description
PRIMARY OBJECTIVE: I. To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma. SECONDARY OBJECTIVES: I. To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma. II. To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma. EXPLORATORY OBJECTIVES: I. T…
Eligibility
- Age range
- Up to 50 years
- Sex
- All
- Healthy volunteers
- No
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 me…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of tissue and blood
- ProcedureComputed Tomography
Undergo CT
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureThoracoscopy
Undergo video-assisted thoracoscopic surgery or VATS
- ProcedureThoracotomy
Undergo open thoracic surgery
Locations (232)
- Children's Hospital of AlabamaBirmingham, Alabama
- Providence Alaska Medical CenterAnchorage, Alaska
- Kingman Regional Medical CenterKingman, Arizona
- Banner Children's at DesertMesa, Arizona
- Phoenix Childrens HospitalPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona