Thoracotomy vs Thoracoscopy for Metastatic Osteosarcoma

Recruiting at 251 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of surgeries for treating lung cancer that has spread from osteosarcoma, a type of bone cancer. One surgery, thoracotomy, involves making a large cut to open the chest. The other, thoracoscopy or Video-Assisted Thoracoscopic Surgery (VATS), uses small cuts and a camera. Researchers aim to determine which method more effectively removes cancer in the lungs. This trial may suit individuals under 50 with osteosarcoma that has spread to their lungs and can be removed by either surgery type. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 prior data suggests that these surgical methods are safe for treating metastatic osteosarcoma?

Research shows that both thoracoscopy (video-assisted thoracoscopic surgery, or VATS) and thoracotomy (open chest surgery) are well-established methods for treating lung problems. Studies have found that thoracoscopy can achieve a success rate of 90% or higher in patients with conditions like non-small cell lung cancer, indicating the procedure is generally safe and well-tolerated.

For thoracotomy, research indicates it is a common method for lung surgeries, including those for cancer that has spread to the lungs. While any surgery carries risks, thoracotomy remains a standard practice, suggesting it is considered safe.

This trial compares both surgical methods to evaluate their effectiveness in treating metastatic osteosarcoma (cancer that has spread to the bones). Participants can feel reassured that these procedures have been used in similar situations and have known safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about comparing thoracoscopy and thoracotomy for treating metastatic osteosarcoma because these surgical methods offer unique advantages. Thoracoscopy, or video-assisted thoracoscopic surgery (VATS), is minimally invasive, which can mean less pain, quicker recovery, and smaller scars compared to the traditional open surgery of thoracotomy. On the other hand, thoracotomy has been the standard method and provides direct access to the lungs, which can be crucial for removing larger tumors. By evaluating these two approaches, researchers hope to identify which method offers better outcomes for patients, balancing effectiveness with quality of life.

What evidence suggests that this trial's treatments could be effective for metastatic osteosarcoma?

This trial will compare thoracotomy and thoracoscopy for treating metastatic osteosarcoma. Research has shown that both thoracotomy (open surgery with a large cut) and thoracoscopy (less invasive surgery using small cuts and a camera) can remove lung tumors in osteosarcoma patients. Studies have found that thoracoscopy often leads to faster recovery and less pain after surgery compared to thoracotomy. However, thoracotomy provides direct access and might be more thorough in removing tumors. The choice between these surgeries depends on the patient's specific needs and the tumor's situation. Both methods aim to control cancer spread and improve survival chances. Participants in this trial will be assigned to either the thoracotomy arm or the thoracoscopy arm to evaluate these outcomes. ^{1 4 5 6 7}

Who Is on the Research Team?

John J Doski

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05235165

Study Details | NCT05235165 | Thoracotomy Versus ... This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS)

2. yalemedicine.org yalemedicine.org/clinical-trials/thoracotomy-versus-thoracoscopic-management-of-pulmonary-metastases-in-patients-with-osteosarcoma

A Phase 3 Randomized Controlled Trial Comparing Open ... This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6753405/

Necessity of thoracotomy in pulmonary metastasis ... After that, the patients were transferred to thoracic surgery for resection of pulmonary metastases. We collected a total of 106 records of surgical operations ...

4. withpower.com withpower.com/trial/phase-3-neoplasms-1-2022-f55e8

Thoracotomy vs Thoracoscopy 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 ...

5. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/thoracotomy-versus-thoracoscopic-management-of-pulmonary-metastases-in-patients-with-osteosarcoma/

A Phase 3 Randomized Controlled Trial Comparing Open vs ... This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4153931/

Safety and feasibility of video-assisted thoracoscopic surgery ... This study was regarded as successful if the surgical success rate reached 90% or higher. Results. A total of 51 patients with non-small cell lung cancer (NSCLC) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9809193/

Role of video-assisted thoracoscopic surgery in pulmonary ... There are sparse prospective studies investigating the role of video-assisted thoracoscopic surgery (VATS) in management of pulmonary metastasis.