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Comparing two surgical methods for lung cancer in osteosarcoma patients

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Phase 3 Interventional Children's Oncology Group · NCT05235165

This study is testing whether open chest surgery or a less invasive approach is better for helping osteosarcoma patients with lung cancer live longer and feel less pain after surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment62 (estimated)
AgesN/A to 50 Years
SexAll
SponsorChildren's Oncology Group Research network
Drugs / interventionsdoxorubicin
Locations232 sites (Birmingham, Alabama and 231 other locations)
Trial IDNCT05235165 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of open thoracic surgery (thoracotomy) versus thoracoscopic surgery (VATS) in treating patients with pulmonary metastases from osteosarcoma. The primary objective is to determine which surgical method leads to better thoracic event-free survival. Secondary objectives include assessing overall survival and post-operative pain interference between the two approaches. The study also explores surgical complications and recurrence patterns associated with each method.

Who should consider this trial

Good fit: Ideal candidates are patients under 50 years old with resectable pulmonary metastases from osteosarcoma.

Not a fit: Patients with more than four lung nodules or those whose nodules are not considered resectable will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could identify the more effective surgical approach for improving survival outcomes in osteosarcoma patients with lung metastases.

How similar studies have performed: Previous studies have shown varying success with surgical approaches for metastatic cancers, but this specific comparison is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.

Exclusion Criteria:

* Patients with unresectable primary tumor.
* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
* Patients with evidence of extrapulmonary metastatic disease.
* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Where this trial is running

Birmingham, Alabama and 231 other locations

+182 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Malignant Neoplasm in the LungMetastatic OsteosarcomaOsteosarcoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.