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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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ClinicalTrials.gov Identifier: NCT05235165
Recruitment Status : Recruiting
First Posted : February 11, 2022
Last Update Posted : September 16, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm in the Lung Metastatic Osteosarcoma Osteosarcoma Other: Questionnaire Administration Procedure: Thoracoscopy Procedure: Thoracotomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : December 15, 2027
Estimated Study Completion Date : December 15, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (thoracotomy)
Patients undergo open thoracic surgery (thoracotomy).
Other: Questionnaire Administration
Ancillary studies

Procedure: Thoracotomy
Undergo open thoracic surgery

Experimental: Arm B (thoracoscopy)
Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS).
Other: Questionnaire Administration
Ancillary studies

Procedure: Thoracoscopy
Undergo video-assisted thoracoscopic surgery or VATS




Primary Outcome Measures :
  1. Thoracic event-free survival (tEFS) [ Time Frame: Four years after enrollment ]
    Estimated four year thoracic event free survival (tEFS) where tEFS is calculated as the time from study enrollment. 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.


Secondary Outcome Measures :
  1. Event free survival (EFS) [ Time Frame: Four years after enrollment ]
    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.

  2. Overall survival (OS) [ Time Frame: Four years after enrollment ]
    Time from study enrollment to death or last patient contact. Patients alive at last contact are considered censored.

  3. Post operative pain interference at time point 3, 7-14 days after surgical intervention [ Time Frame: 7-14 days after surgical intervention ]
    Total PROMIS pain interference score from the 8 item PROMIS pain interference short form.

  4. Post operative pain interference at time point 4, 4-6 weeks after surgical intervention [ Time Frame: 4-6 weeks after surgical intervention ]
    Total PROMIS pain interference score from the 8 item PROMIS pain interference short form.


Other Outcome Measures:
  1. Perioperative surgical complications [ Time Frame: At 30 days post-op ]
    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.

  2. Mode of tEFS event [ Time Frame: Four years after enrollment ]
    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.

  3. Use of localization techniques [ Time Frame: 12 months after enrollment ]
    Data collection will include a description of all localization methods used.

  4. Decision to change the post-operative treatment plan [ Time Frame: 12 months after enrollment ]
    Whether the investigator adhered to the post-thoracic surgery plan for systemic therapy.

  5. Radiological features to the presence of viable tumor [ Time Frame: 12 months after enrollment ]
    Radiological features and pathological characteristics of lung nodules contributed by the same patient.

  6. Post operative upper extremity function at time point 2, 24-48 hours after surgical intervention [ Time Frame: 24-48 hours after surgical intervention ]
    Total PROMIS upper extremity score from the 8 item PROMIS upper extremity short form.

  7. Post operative upper extremity function at time point 3, 7-14 days after surgical intervention [ Time Frame: 7-14 days after surgical intervention ]
    Total PROMIS upper extremity score from the 8 item PROMIS upper extremity short form.

  8. Post operative pain intensity at time point 2, 24-48 hours after surgical intervention [ Time Frame: 24-48 hours after surgical intervention ]
    NRS 11 single item pain intensity score.

  9. Post operative pain intensity at time point 3, 7-14 days after surgical intervention [ Time Frame: 7-14 days after surgical intervention ]
    NRS 11 single item pain intensity score.

  10. Frequency of obtaining quality tumor tissue for biological analysis [ Time Frame: 1 month after surgical intervention ]
    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.



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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be < 50 years at the time of enrollment.
  • Patient must have eligibility confirmed by rapid central imaging review.

    • 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.
  • 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 systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
  • Patients at time of 1st recurrence must have previously completed initial systemic therapy for their primary tumor, considered by the treating physician as at least equivalent to MAP.

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 pleural or mediastinal based metastatic lesions, or with 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05235165


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John J Doski Children's Oncology Group
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT05235165    
Other Study ID Numbers: AOST2031
NCI-2021-14237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AOST2031 ( Other Identifier: Children's Oncology Group )
AOST2031 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma