A Phase 3 interventional study of Biospecimen Collection and Computed Tomography in Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma and Osteosarcoma, sponsored by Children's Oncology Group. Recruiting at 233 sites in 6 countries. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Children's Oncology Group · Phase 3, Interventional, and Treatment
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.
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.
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's planned enrollment of 62 is above the median of 40 across 354 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →Children's Oncology Group is the lead sponsor of 448 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have =\< 4 nodules per lung consistent with or suspicious for , with at least one of which being >= 3 mm and all of which must be =\< 3 cm size.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo open thoracic surgery (thoracotomy). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.
Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Questionnaire Administration · Procedure: Thoracotomy
Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.
Procedure: Biospecimen Collection · Other: Questionnaire Administration · Procedure: Thoracoscopy
Undergo collection of tissue and blood
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Ancillary studies
Undergo video-assisted thoracoscopic surgery or VATS
Also known as: Pleuroscopy
Undergo open thoracic surgery
Also known as: incision of Chest Wall, Incision of Thorax
Thoracic event-free survival (tEFS)
Estimated four year thoracic event free survival (tEFS) where tEFS is calculated as the time from study enrollment to thoracic cavity event. Any recurrence within the pulmonary parenchyma, involving the pleural surface or the drain/surgical site wound will be considered an event. A death that results from the procedure, as confirmed by the treating physician, will be considered an event. Patients with recurrences arising outside the thoracic region, the diagnosis of a malignancy that is not osteosarcoma (SMN) or death considered unrelated to the study surgical procedure, as confirmed by the treating physician will be considered competing events provided these occur prior to a thoracic cavity event as defined above. Patients without an event of any kind at last contact are considered censored.
Time frame: Four years after enrollment
Event free survival (EFS)
Estimated four year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Patients without an event at last contact are considered censored.
Time frame: Four years after enrollment
Overall survival (OS)
Time from study enrollment to death or last patient contact. Patients alive at last contact are considered censored.
Time frame: Four years after enrollment
Perioperative surgical complications
The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be utilized for AE reporting.
Time frame: At 30 days post-op
Mode of tEFS event
Classified as: (1) ipsilateral recurrence site; (2) contralateral recurrence site; or (3) ipsilateral and contralateral recurrence site. The analysis will be restricted to patients with unilateral disease at enrollment.
Time frame: Four years after enrollment
Use of localization techniques
Data collection will include a description of all localization methods used.
Time frame: 12 months after enrollment
Decision to change the post-operative treatment plan
Whether the investigator adhered to the post-thoracic surgery plan for systemic therapy.
Time frame: 12 months after enrollment
Radiological features to the presence of viable tumor
Radiological features and pathological characteristics of lung nodules contributed by the same patient.
Time frame: 12 months after enrollment
Post operative pain intensity at time point 2, 48 hours after surgical intervention
NRS 11 single item pain intensity score.
Time frame: 48 hours after surgical intervention
Frequency of obtaining quality tumor tissue for biological analysis
Tumor samples obtained from the surgical procedure that are submitted to the COG tissue bank and subjected to dual nucleic acid extraction will be classified by central review as to whether sufficient tumor content was obtained for ultra low passage whole genome sequencing.
Time frame: 1 month after surgical intervention
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