Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
This study, called a Phase 3 clinical trial, is looking at the best way to remove cancerous growths (metastases) from the lungs in people with osteosarcoma. Osteosarcoma is a type of bone cancer. When it spreads to the lungs, doctors sometimes need to operate to remove these spots. The trial compares two surgical methods: open surgery (thoracotomy), which involves a larger cut to access the lung, and keyhole surgery (thoracoscopy or VATS), which uses several small cuts and a camera. Researchers want to find out which method leads to better outcomes for patients, such as how long they remain free from new growths in the chest and overall survival. They will also look at side effects, recovery, and how these surgeries compare in different situations.
At a glance
What is this study about?
This study is designed to help doctors understand the best way to treat osteosarcoma that has spread to the lungs. Osteosarcoma is a type of cancer that starts in the bone. Unfortunately, it can sometimes spread to other parts of the body, and the lungs are a common place for this to happen. When cancer spreads, these new growths are called metastases. In some cases, surgeons can remove these lung metastases to help patients.
There are two main surgical approaches for removing these lung growths:
1. **Open surgery (thoracotomy):** This is a more traditional operation where the surgeon makes one larger cut between the ribs to open the chest. This allows them to see and access the lung directly to remove the cancerous spots.
2. **Keyhole surgery (thoracoscopy, or VATS):** This is a less invasive method. The surgeon makes several small cuts and uses a small camera to see inside the chest. They then use special tools inserted through these small cuts to remove the cancerous areas.
The main goal of this study is to compare these two types of surgery. The researchers want to find out if one method is more effective than the other in preventing the cancer from growing back in the chest (this is called 'thoracic event-free survival') and if it helps people live longer overall. They will also look at how quickly people recover, any problems that might arise during or after surgery, and examine the removed tissue to learn more about the cancer.
Key takeaways
- Compares two lung surgeries for osteosarcoma that's spread to the lungs.
- Aims to find out if open surgery or keyhole surgery is better.
- Participation involves either open or keyhole surgery, plus scans and questionnaires.
- The study helps improve future care for patients with osteosarcoma.
- You can be up to 50 years old and have specific lung spot requirements.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, you need to be under 50 years old. You must have spots in your lungs that doctors think are cancerous, with no more than four spots in each lung. These spots must be at least 3mm in size but no larger than 3cm, and your surgeon must believe they can be removed by either open or keyhole surgery.
You also need to have a confirmed diagnosis of osteosarcoma. The lung spots must have been found either when you were first diagnosed with osteosarcoma or when the cancer came back for the first time after initial treatment. If you've recently been diagnosed, your main bone tumour must have been successfully removed, or plans must be in place to remove it at the same time as the lung surgery. You should also be receiving, or have recently finished (within 60 days), standard chemotherapy treatment for osteosarcoma.
You cannot join the study if your main bone tumour cannot be removed. You also cannot participate if the lung spots are too large, would require a larger lung removal (like a whole lobe or lung), or are located too centrally in the lung to be safely removed without removing a larger section of the lung.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you under 50 years old?
- Do you have a confirmed diagnosis of osteosarcoma?
- Have you been told you have up to 4 cancerous spots in each lung, with each spot between 3mm and 3cm in size, that your surgeon believes can be removed?
- Have you recently completed (within 60 days) or are you currently receiving standard chemotherapy for osteosarcoma?
- Has your primary bone tumour been successfully removed, or is it planned to be removed at the same time as the lung surgery?
- Are your lung spots not too large or located too centrally in the lung that they would require a larger portion of the lung to be removed?
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either open surgery (thoracotomy) or keyhole surgery (thoracoscopy/VATS). This is like flipping a coin, so neither you nor your doctor can choose which surgery you will have. Before and after your surgery, you will have various assessments. This includes CT scans of your chest to look at the lung spots, and you might be asked to fill out questionnaires about how you are feeling and your quality of life. Doctors will also collect small samples of your tissue during surgery for further study. The study involves your surgery itself, follow-up appointments, and ongoing observation to track your recovery and health over time. The total duration of your participation will depend on the long-term follow-up required by the study.
Potential risks and benefits
Locations (232)
- Children's Hospital of AlabamaVerified postcodeBirmingham, United States· Recruiting
- Providence Alaska Medical CenterVerified postcodeAnchorage, United States· Recruiting
- Kingman Regional Medical CenterVerified postcodeKingman, United States· Recruiting
- Banner Children's at DesertVerified postcodeMesa, United States· Recruiting
- Phoenix Childrens HospitalVerified postcodePhoenix, United States· Recruiting
- Banner University Medical Center - TucsonVerified postcodeTucson, United States· Recruiting
- Arkansas Children's HospitalVerified postcodeLittle Rock, United States· Recruiting
- Kaiser Permanente-AnaheimVerified postcodeAnaheim, United States· Recruiting
- PCR OncologyVerified postcodeArroyo Grande, United States· Recruiting
- Kaiser Permanente-BellflowerVerified postcodeBellflower, United States· Recruiting
- Kaiser Permanente Downey Medical CenterVerified postcodeDowney, United States· Recruiting
- Kaiser Permanente-FontanaVerified postcodeFontana, United States· Recruiting
Common questions
What is osteosarcoma?
Osteosarcoma is a type of cancer that starts in the bone. It's the most common kind of bone cancer among children, teenagers, and young adults.
What does 'metastases' mean?
When cancer spreads from where it started to another part of the body, the new growths are called metastases. In this study, it refers to osteosarcoma that has spread to the lungs.
What's the difference between open surgery and keyhole surgery for the lung?
Open surgery involves one larger cut between the ribs to allow direct access to the lung. Keyhole surgery uses several small cuts and a camera to guide the surgeon in removing the spots with special tools.
Why is this study important?
This study aims to find out which of the two surgical methods is more effective for removing cancerous lung spots in people with osteosarcoma, to help doctors provide the best possible treatment in the future.
What is a 'Phase 3' trial?
A Phase 3 trial is a key step in testing new treatments or comparing existing ones. It usually involves a larger group of patients and aims to confirm how well a treatment works and its safety, often comparing it to standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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