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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
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.
Study details:
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. III.
To determine if thoracoscopy is superior to open surgical resection for post-operative pain interference 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 prospectively compare between treatment arms the relationship between surgical approach and patient-reported outcomes (PROs), specifically patient functional impairment of the upper extremities, pain intensity, and health-related quality of life (HRQoL). VII.
To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma. VIII. 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-04-01
Primary completion: 2031-03-31
Study completion finish: 2031-03-31
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05235165
Intervention or treatment
PROCEDURE: Biospecimen Collection
PROCEDURE: Computed Tomography
OTHER: Questionnaire Administration
PROCEDURE: Thoracoscopy
PROCEDURE: Thoracotomy
Conditions
- • Metastatic Malignant Neoplasm in the Lung
- • Metastatic Osteosarcoma
- • Osteosarcoma
Find a site
Closest Location:
Perth Children's Hospital
Research sites nearby
Select from list below to view details:
Perth Children's Hospital
Perth, Western Australia, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm A (thoracotomy)
| PROCEDURE: Biospecimen Collection
|
EXPERIMENTAL: Arm B (thoracoscopy)
| PROCEDURE: Biospecimen Collection
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Thoracic event-free survival (tEFS) | 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. | Four years after enrollment |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | 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. | Four years after enrollment |
Post operative pain interference at time point 3, 7-14 days after surgical intervention | Total PROMIS pain interference score from the 8 item PROMIS pain interference short form. | 7-14 days after surgical intervention |
Post operative pain interference at time point 4, 4-6 weeks after surgical intervention | Total PROMIS pain interference score from the 8 item PROMIS pain interference short form. | 4-6 weeks after surgical intervention |
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