COG AOST2031

Clinical Trial Title A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
Trial Status Open to Enrollment
Start Date 04/01/2022
Location Randall Children's Hospital at Legacy Emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Metastatic Malignant Neoplasm in the Lung Metastatic Osteosarcoma Osteosarcoma
Description 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.
Eligibility Criteria

Eligible Patients

  • 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 metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
  • 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.
  • Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
  • Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.

 

Please contact Legacy's Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel for additional study inclusion/exclusion information.

 

 
IRB Number Central IRB
Notes

Study Details | NCT05235165 | Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma | ClinicalTrials.gov
Principal Investigator Jason Glover, MD
Contact Name Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel
Contact Phone 503-276-9300
Contact Fax 503-276-9351
Contact E-Mail childcanc@LHS.ORG