Thoracotomy vs Thoracoscopy for Metastatic Osteosarcoma

Recruiting at 232 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Must be taking: Cisplatin-doxorubicin, Ifosfamide

Disqualifiers: Unresectable tumor, Central lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, newly diagnosed patients must have completed or be receiving standard systemic therapy for osteosarcoma, so it's possible you may need to continue certain treatments.

What data supports the effectiveness of the treatment Thoracoscopy, Video-Assisted Thoracoscopic Surgery, VATS, Minimally Invasive Thoracic Surgery, Thoracotomy, Open Thoracic Surgery for metastatic osteosarcoma?

Research shows that both thoracotomy (open surgery) and thoracoscopy (minimally invasive surgery) can be used to remove lung metastases in osteosarcoma patients, with similar survival outcomes. Thoracoscopy may have better perioperative results, making it a suitable alternative to open surgery for some patients. ^{1 2 3 4 5}

Is thoracoscopy (VATS) generally safe compared to thoracotomy?

Video-assisted thoracic surgery (VATS) is considered a safe and minimally invasive option compared to open thoracotomy, with studies suggesting it can be safely performed for conditions like lung cancer and pulmonary metastases. However, there are concerns about the need for emergency conversion to open thoracotomy during surgery, which could lead to complications. ^{1 2 6 7 8}

How does the treatment of thoracotomy vs thoracoscopy for metastatic osteosarcoma differ from other treatments?

Thoracotomy and thoracoscopy are surgical treatments for removing lung metastases in osteosarcoma patients. Thoracotomy allows surgeons to feel for nodules that might not show up on scans, while thoracoscopy is less invasive and uses a camera to guide the surgery. Both approaches aim to remove all visible tumors, but there is no clear evidence that one method leads to better survival outcomes than the other. ^{1 2 3 4 9}

Research Team

John J Doski

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients under 50 with osteosarcoma that has spread to the lungs. They must have fewer than four small lung nodules, each no larger than 3 cm, and be on or have completed a specific chemotherapy regimen (MAP). Patients can't join if they've had previous lung surgery for metastasis, have an unresectable primary tumor, pleural or mediastinal lesions, pleural effusion, or central pulmonary lesions requiring lobectomy.

Inclusion Criteria

My lung nodules can be surgically removed.

I have had or will have surgery to remove my primary tumor.

I have up to 4 lung nodules, each no larger than 3 cm, with at least one being at least 3 mm.

Exclusion Criteria

I had surgery on my lungs to remove cancer before joining this study.

My cancer has spread to my chest wall, mediastinum, or caused significant fluid around my lungs.

My cancer has spread beyond my lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either open thoracic surgery (thoracotomy) or thoracoscopy (video-assisted thoracoscopic surgery or VATS) to treat pulmonary metastases.

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 7-14 days, 4-6 weeks, and 3 months post-surgery, then every 3 months for up to 2 years.

2 years

Multiple visits (in-person)

Treatment Details

Interventions

• Thoracoscopy
• Thoracotomy

Trial Overview The study compares two surgical methods for removing lung metastases in osteosarcoma patients: open thoracic surgery (thoracotomy) versus minimally invasive thoracoscopy (VATS). The goal is to determine which method is more effective for these patients.

Participant Groups

Group I: Arm B (thoracoscopy) Experimental Treatment 3 Interventions

Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.

Group II: Arm A (thoracotomy) Experimental Treatment 4 Interventions

Patients undergo open thoracic surgery (thoracotomy). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.

Thoracoscopy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Approved in European Union as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema
• Thoracic sympathectomy

Approved in Canada as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Approved in Japan as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Video-assisted thoracic surgery (VATS) is a safe and effective diagnostic tool for children with metastatic pulmonary osteosarcoma, providing valuable biopsy material in all cases where it was used (n = 7).

VATS can complement open thoracotomy and may allow for less invasive procedures, with a mean operative time of 1.78 hours and a hospital stay of 3.5 days, although there were two complications reported, including one requiring a transfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-assisted thoracic surgery (VATS) for children with pulmonary metastases from osteosarcoma. Gilbert, JC., Powell, DM., Hartman, GE., et al.[2019]

Video-assisted thoracoscopic surgery (VATS) for pulmonary metastasectomy showed a statistically significant higher overall survival rate compared to traditional open thoracotomy, with a hazard ratio of 0.69 based on a meta-analysis of 8 studies involving 822 patients.

No significant difference in recurrence-free survival rates was found between VATS and open thoracotomy, suggesting that while VATS may improve overall survival, it does not affect the likelihood of cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-assisted thoracoscopic surgery versus open thoracotomy in pulmonary metastasectomy: a meta-analysis of observational studies. Meng, D., Fu, L., Wang, L., et al.[2018]

In a study of 202 pediatric patients with osteosarcoma, there was no significant difference in overall survival (OS) or pulmonary disease-free survival (DFS) between those who underwent thoracotomy and those who had thoracoscopic surgery, suggesting both methods are similarly effective for metastasectomy.

While thoracoscopic surgery was associated with a higher risk of mortality overall, this risk was not present in patients with oligometastatic disease, indicating that thoracoscopy may be a safe option for this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracoscopy vs thoracotomy for the management of metastatic osteosarcoma: A Pediatric Surgical Oncology Research Collaborative Study. Lautz, TB., Farooqui, Z., Jenkins, T., et al.[2022]

In a study of 61 osteosarcoma patients undergoing surgery for pulmonary metastases, no significant difference in survival outcomes was found between thoracotomy and thoracoscopic approaches.

However, thoracotomy was associated with higher rates of postoperative complications, such as pain and prolonged hospital stays, indicating it may not be the preferred surgical method for managing pulmonary metastases in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival outcomes and surgical morbidity based on surgical approach to pulmonary metastasectomy in pediatric, adolescent and young adult patients with osteosarcoma. Kuo, C., Malvar, J., Chi, YY., et al.[2023]

Video-assisted thoracic surgery (VATS) for pulmonary metastasectomy shows comparable survival rates to traditional open thoracotomy (OT), indicating it is a viable alternative for patients with pulmonary metastases.

VATS is associated with better perioperative outcomes than OT, suggesting it may offer advantages in recovery and overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a thoracoscopic approach provide better outcomes for pulmonary metastases? Rusidanmu, A., Chin, W., Xu, J., et al.[2021]

In a study of 30 patients who required conversion from video-assisted thoracoscopic surgery (VATS) to open thoracotomy, there were no significant differences in postoperative complications compared to matched controls who underwent open thoracotomy, indicating that conversion does not negatively impact short-term outcomes.

Long-term survival rates were also similar between the converted VATS group and the open thoracotomy group, suggesting that VATS lobectomy remains a safe and effective treatment option for stage I and II non-small cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does failed video-assisted lobectomy for lung cancer prejudice immediate and long-term outcomes? Jones, RO., Casali, G., Walker, WS.[2022]

In a study of 69 patients who underwent thoracotomy for pulmonary metastases of osteosarcoma, preoperative CT scans often underestimated the number of metastatic nodules, with 37.5% of surgeries revealing more nodules than initially detected by CT.

The findings suggest that thoracotomy remains necessary for accurately locating and resecting all metastatic nodules, as preoperative imaging may miss small metastases, highlighting the importance of direct intraoperative assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Necessity of thoracotomy in pulmonary metastasis of osteosarcoma. Gao, E., Li, Y., Zhao, W., et al.[2022]

Video-assisted thoracic surgery (VATS) lobectomy is a safe and effective minimally invasive option for treating early-stage non-small cell lung cancer, addressing concerns about its adequacy compared to traditional open thoracotomy.

Despite the promising evidence for VATS lobectomy, there is a need for more robust studies that directly compare its outcomes with those of open thoracotomy to fully establish its safety and efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-assisted thoracic surgery lobectomy (VATS), open thoracotomy, and the robot for lung cancer. Flores, RM., Alam, N.[2023]

A survey of 204 pediatric surgeons revealed that there is no consensus on the preferred surgical approach for removing pulmonary metastases in children with osteosarcoma, with 34% favoring thoracoscopy for 3 nodules and only 21% for 5 nodules.

The majority of surgeons (84%) are interested in participating in a randomized controlled trial to compare the effectiveness of thoracotomy versus thoracoscopy, highlighting the need for more definitive research to determine the best surgical management for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current surgical management of children with osteosarcoma and pulmonary metastatic disease: A survey of the American Pediatric Surgical Association. Lautz, TB., Krailo, MD., Han, R., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Video-assisted thoracic surgery (VATS) for children with pulmonary metastases from osteosarcoma. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Video-assisted thoracoscopic surgery versus open thoracotomy in pulmonary metastasectomy: a meta-analysis of observational studies. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Thoracoscopy vs thoracotomy for the management of metastatic osteosarcoma: A Pediatric Surgical Oncology Research Collaborative Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Survival outcomes and surgical morbidity based on surgical approach to pulmonary metastasectomy in pediatric, adolescent and young adult patients with osteosarcoma. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Does a thoracoscopic approach provide better outcomes for pulmonary metastases? [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Does failed video-assisted lobectomy for lung cancer prejudice immediate and long-term outcomes? [2022]

7. China pubmed.ncbi.nlm.nih.gov

Necessity of thoracotomy in pulmonary metastasis of osteosarcoma. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Video-assisted thoracic surgery lobectomy (VATS), open thoracotomy, and the robot for lung cancer. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Current surgical management of children with osteosarcoma and pulmonary metastatic disease: A survey of the American Pediatric Surgical Association. [2021]