Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
S
Sandeep Batra, MD
Primary Investigator
Overview
This phase III trial compares the effect of open thoracic surgery (thoracotomy) tohoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients
with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgeryype 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 chesturgery where the doctor makes several small incisions and uses a small camera to help withving the cancer. This trial is being done evaluate the two different surgery methods forwith osteosarcoma that has spread to the lung to find out which is better.
Description
PRIMARY OBJECTIVE:
I. To determine if open surgical resection is superior to thoracoscopic resection forhoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary.
SECONDARY OBJECTIVES:
I. To determine if open surgical resection is superior to thoracoscopy for event freeurvival (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.
III. To determine if thoracoscopy is superior to open surgical resection for post-operativewith resectable oligometastatic pulmonary osteosarcoma.
EXPLORATORY OBJECTIVES:
I. To compare 30-day rates of perioperative surgical complications for both open surgicald 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 surgicalh and pathologic findings.
IV. To assess the prognostic significance of a decision to change the post-operative.
V. To describe the relationship between the preoperative chest computed tomography (CT)ging, intraoperative surgical findings, and pathologic results, comparing radiologicalures to the presence of viable tumor.
VI. To prospectively compare between treatment arms the relationship between surgicalh and patient-reported outcomes (PROs), specifically patient functional impairment ofhe upper extremities, pain intensity, and health-related quality of life (HRQoL).
VII. To generate well-characterized, clinically-annotated, distributable models of metastatic.
VIII. To collect and bank pulmonary metastatic lesions (including frozen tissues and pairedg from the same patient) to facilitate study of metastatic diseased 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 undergoue on study and blood throughout the trial.
After completion of study treatment, patients are followed up at 7-14 days, 4-6 weeks, and 3hs post-surgery and then every 3 months for up to 2 years.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
-
Age: - 50 Years
-
Gender: All
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 initialdiagnosis, or at time of 1st recurrence following completion of therapy for initiallyzed disease.
- Patients with newly diagnosed disease must have completed successful gross tumorheir primary tumor or surgical local control of primary tumor must bed to be performed simultaneously with thoracic surgery.
- Newly diagnosed patients must be receiving systemic therapy considered by the treatinghysician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) athe time of enrollment on this study.
- Patients at time of 1st recurrence must have previously completed initial systemicherapy for their primary tumor, considered by the treating physician as at leastquivalent 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., centralvolves or is proximal to segmental bronchi and peripheral is lesion distal togmental bronchi).
- Patients with pleural or mediastinal based metastatic lesions, or with pleuralusion.
- Patients with disease progression at either the primary or pulmonary metastatic sitewhile on initial therapy. Note: Once the patient has been enrolled on the study,dditional computed tomography (CT) scans are not anticipated prior to thoracicurgery. Note: Some variation in nodule size measurements over the course ofve therapy is anticipated and does not qualify for exclusion unless deemedue 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.
- All patients and/or their parents or legal guardians must sign a written informed.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute(NCI) requirements for human studies must be met.
Updated on
30 Apr 2024.
Study ID: AOST2031
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