Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
About
A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
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. Patient will be randomized to one of two types of surgery. Open thoracic surgery is a type of surgery done through a single larger incision 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 to help evaluate the effectiveness between the two different surgery methods for patients with osteosarcoma that has spread to the lung.
Study Plan: This trial wants to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival in patients with resectable oligometastatic pulmonary osteosarcoma. Patients will be randomized to one of two arms:
Arm 1: open thoracic surgery (thoracotomy)
Arm 2: video assisted thoracic surgery (thoracoscopy)
COG # AOST2031
Eligibility Criteria
Inclusion Criteria
- Diagnosis: 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 first recurrence following completion of therapy for initially localized disease. Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one being ≥ 3 mm and all being ≤ 3 cm size
- Age: Patients must be < 50 years at the time of enrollment
- Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery
Exclusion Criteria
- Patients with unresectable primary tumor
- Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy
- Patients who received pulmonary surgery for lung metastasis prior to enrollment
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. With over 30 years of clinical experience, he is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, CCRP
Clinical Research Coordinator
Sydnee Moses, BS
Clinical Research Coordinator
