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NCT05235165 · CITED IN SOURCE DOCUMENTS

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
RECRUITING
Registry last update
2026-08-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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.
healthy Volunteers
false
maximum Age
50 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Procedure: Computed Tomography
    3. Other: Questionnaire Administration
    4. Procedure: Thoracotomy
    label
    Arm A (thoracotomy)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Other: Questionnaire Administration
    3. Procedure: Thoracoscopy
    label
    Arm B (thoracoscopy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A (thoracotomy)
    2. Arm B (thoracoscopy)
    description
    Undergo collection of tissue and blood
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Specimen Collection
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm A (thoracotomy)
    description
    Undergo CT
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Axial Tomography
    4. Computerized Axial Tomography
    5. Computerized axial tomography (procedure)
    6. Computerized Tomography
    7. Computerized Tomography (CT) scan
    8. CT
    9. CT Scan
    10. Diagnostic CAT Scan
    11. Diagnostic CAT Scan Service Type
    12. tomography
    type
    PROCEDURE
  3. arm Group Labels
    1. Arm A (thoracotomy)
    2. Arm B (thoracoscopy)
    description
    Ancillary studies
    name
    Questionnaire Administration
    type
    OTHER
  4. arm Group Labels
    1. Arm B (thoracoscopy)
    description
    Undergo video-assisted thoracoscopic surgery or VATS
    name
    Thoracoscopy
    other Names
    1. Pleuroscopy
    type
    PROCEDURE
  5. arm Group Labels
    1. Arm A (thoracotomy)
    description
    Undergo open thoracic surgery
    name
    Thoracotomy
    other Names
    1. incision of Chest Wall
    2. Incision of Thorax
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
62
type
ESTIMATED
Registered outcome plans (not posted results)
other Outcomes
  1. description
    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.
    measure
    Perioperative surgical complications
    time Frame
    At 30 days post-op
  2. description
    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.
    measure
    Mode of tEFS event
    time Frame
    Four years after enrollment
  3. description
    Data collection will include a description of all localization methods used.
    measure
    Use of localization techniques
    time Frame
    12 months after enrollment
  4. description
    Whether the investigator adhered to the post-thoracic surgery plan for systemic therapy.
    measure
    Decision to change the post-operative treatment plan
    time Frame
    12 months after enrollment
  5. description
    Radiological features and pathological characteristics of lung nodules contributed by the same patient.
    measure
    Radiological features to the presence of viable tumor
    time Frame
    12 months after enrollment
  6. description
    NRS 11 single item pain intensity score.
    measure
    Post operative pain intensity at time point 2, 48 hours after surgical intervention
    time Frame
    48 hours after surgical intervention
  7. description
    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.
    measure
    Frequency of obtaining quality tumor tissue for biological analysis
    time Frame
    1 month after surgical intervention
primary Outcomes
  1. description
    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.
    measure
    Thoracic event-free survival (tEFS)
    time Frame
    Four years after enrollment
secondary Outcomes
  1. description
    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.
    measure
    Event free survival (EFS)
    time Frame
    Four years after enrollment
  2. description
    Time from study enrollment to death or last patient contact. Patients alive at last contact are considered censored.
    measure
    Overall survival (OS)
    time Frame
    Four years after enrollment
Full study description
brief 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.
Source references
Source notices and limitations
    Discovery and provenance
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        racoscopy did not increase the risk of mortality (HR, 1.16; 95% CI, 0.64&#8211;2.11; <em>P</em> = .62). The ongoing randomized trial (<a href="/clinicaltrials/NCT05235165">AOST2031 [NCT05235165]</a>) was designed to definitively address this question and the selection bias. This trial will compare the effect of thoracotomy with
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        ase the risk of mortality (HR, 1.16; 95% CI, 0.64&#8211;2.11; <em>P</em> = .62). The ongoing randomized trial (<a href="/clinicaltrials/NCT05235165">AOST2031 [NCT05235165]</a>) was designed to definitively address this question and the selection bias. This trial will compare the effect of thoracotomy with thoracoscopic surgery.<
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        r institutional clinical trials that are currently being conducted:</p> <div class="pdq-content-list"><ul id="_2403"><li><strong><a href="/clinicaltrials/NCT05235165">AOST2031 (NCT05235165)</a></strong> (Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma)<strong>:</strong> This
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        l trials that are currently being conducted:</p> <div class="pdq-content-list"><ul id="_2403"><li><strong><a href="/clinicaltrials/NCT05235165">AOST2031 (NCT05235165)</a></strong> (Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma)<strong>:</strong> This phase III trial compar
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        oracoscopy did not increase the risk of mortality (HR, 1.16; 95% CI, 0.64&#8211;2.11; <em>P</em> = .62). The ongoing randomized trial (<a href="/clinicaltrials/NCT05235165">AOST2031 [NCT05235165]</a>) was designed to definitively address this question and the selection bias. This trial will compare the effect of thoracotomy with
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        ease the risk of mortality (HR, 1.16; 95% CI, 0.64&#8211;2.11; <em>P</em> = .62). The ongoing randomized trial (<a href="/clinicaltrials/NCT05235165">AOST2031 [NCT05235165]</a>) was designed to definitively address this question and the selection bias. This trial will compare the effect of thoracotomy with thoracoscopic surgery.<
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        pathological examination.</li></ul></div></li></ol></div> <p id="_2429" tabindex="-1">The COG is conducting a randomized trial (<a href="/clinicaltrials/NCT05235165">AOST2031 [NCT05235165]</a>) to compare the effect of thoracotomy with thoracoscopic surgery to remove lung metastases. For more information, see the <a href="
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        on.</li></ul></div></li></ol></div> <p id="_2429" tabindex="-1">The COG is conducting a randomized trial (<a href="/clinicaltrials/NCT05235165">AOST2031 [NCT05235165]</a>) to compare the effect of thoracotomy with thoracoscopic surgery to remove lung metastases. For more information, see the <a href="/types/bone/hp/osteosar
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        phase I trial to determine the side effects and best dose of GD2CART to be effective against GD2-positive tumor cells.</li><li><strong><a href="/clinicaltrials/NCT05235165">AOST2031 (NCT05235165)</a></strong> (Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma)<strong>:</strong> This
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        ine the side effects and best dose of GD2CART to be effective against GD2-positive tumor cells.</li><li><strong><a href="/clinicaltrials/NCT05235165">AOST2031 (NCT05235165)</a></strong> (Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma)<strong>:</strong> This phase III trial compar
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      source update dates
      1. context
        Updated: December 2, 2024
        datetime
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        December 2, 2024

    Preserved source evidence · Not medical advice