BridgeMD
Compares treatment options for Metastatic Malignant Neoplasm in the Lung
Official title Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
ClinicalTrials.gov ID: NCT05235165
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 50
You may be able to join if
- Patients must be \< 50 years at the time of enrollment.
- Patients must have =\ = 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...
- Patients must have a histological diagnosis of osteosarcoma.
You likely can't join if
- Patients with unresectable primary tumor.
- Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as...
- 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...
- Patients with evidence of extrapulmonary metastatic disease.
- Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
See the full eligibility criteria
- Patients must be \< 50 years at the time of enrollment.
- Patients must have =\ = 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Kingman, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Bellflower, California, United States
- Downey, California, United States
- Fontana, California, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Madera, California, United States
- Oakland, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
+ 137 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Kingman, Arizona, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States and 151 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.