Comparing Two Types of Lung Surgery for Osteosarcoma Patients with Lung Metastases

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05235165

Provider View

This study is comparing two surgical methods—open surgery and minimally invasive surgery—to see which is more effective for patients with osteosarcoma that has spread to the lungs.

Patient Parameters

Program Overview

This clinical trial is exploring two different surgical approaches for treating osteosarcoma that has spread to the lungs. The first method is open thoracic surgery, which involves a larger incision to remove the cancer. The second method is thoracoscopic surgery, which uses smaller incisions and a camera to assist in removing the cancer. The goal is to determine which method is more effective in treating lung metastases in osteosarcoma patients.

Description

The main goal of this study is to find out if open surgery is better than thoracoscopic surgery for preventing cancer events in the chest area for patients with osteosarcoma that has spread to the lungs. Secondary goals include comparing overall survival rates and post-surgery pain between the two methods. The study will also look at surgical complications, cancer recurrence patterns, and patient-reported outcomes like pain and quality of life.

Participants will be randomly assigned to one of two groups: one group will have open thoracic surgery, and the other will have thoracoscopic surgery. All participants will have CT scans during the study and may provide tissue and blood samples for research. After surgery, follow-up visits will occur at 7-14 days, 4-6 weeks, and 3 months, and then every 3 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be under 50 years old.
  • Have 4 or fewer lung nodules, with at least one being 3 mm or larger, and all nodules 3 cm or smaller.
  • Lung nodules must be removable by either surgery method.
  • Must have a confirmed diagnosis of osteosarcoma.
  • Must have lung metastases at initial diagnosis or first recurrence after treatment.
  • Newly diagnosed patients must have had or plan to have primary tumor surgery.
  • Must be receiving or have recently completed standard osteosarcoma treatment.
  • Patients at first recurrence must have completed initial treatment.

Exclusion Criteria

  • Cannot have an unresectable primary tumor.
  • Cannot have lung lesions requiring major lung resection or central lesions.
  • Cannot have chest wall or mediastinal lesions, or significant fluid in the chest.
  • Cannot have disease progression during initial therapy.
  • Cannot have metastases outside the lungs.
  • Cannot have had lung surgery for metastases before joining the study.
  • Must provide informed consent.
  • Must meet all regulatory requirements for human studies.

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