NCT05235165

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. To compare 30-day rates of perioperative surgical complications for both open surgical resection and thoracoscopy. II. To compare patterns of recurrence (ipsilateral and/or contralateral) in patients who undergo open or thoracoscopic resection for unilateral or bilateral pulmonary metastases. III. To describe the use of localization techniques and its relationship with both surgical approach and pathologic findings. IV. To assess the prognostic significance of a decision to change the post-operative treatment plan. V. To describe the relationship between the preoperative chest computed tomography (CT) imaging, intraoperative surgical findings, and pathologic results, comparing radiological features to the presence of viable tumor. VI. To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma. VII. To collect and bank pulmonary metastatic lesions (including frozen tissues and paired metastatic lesions coming from the same patient) to facilitate study of metastatic disease and serial blood samples for future tumor profiling, germline and circulating tumor deoxyribonucleic acid (DNA) studies. OUTLINE: Patients are randomized into 1 of 2 arms. ARM A: Patients undergo open thoracic surgery (thoracotomy). ARM B: Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). All patients undergo computed tomography (CT) throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial. After completion of study treatment, patients are followed up at 7-14 days, 4-6 weeks, and 3 months post-surgery and then every 3 months for up to 2 years.

Conditions

• Metastatic Malignant Neoplasm in the Lung
• Metastatic Osteosarcoma
• Osteosarcoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of tissue and blood
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Thoracoscopy	Undergo video-assisted thoracoscopic surgery or VATS
PROCEDURE	Thoracotomy	Undergo open thoracic surgery

Timeline

• Start date: 2022-04-01
• Primary completion: 2031-03-31
• Completion: 2031-03-31
• First posted: 2022-02-11
• Last updated: 2026-02-27

Locations

232 sites across 6 countries: United States, Australia, Canada, New Zealand, Puerto Rico, Saudi Arabia

Regulatory

• FDA-regulated device study