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Procedure

Thoracotomy vs Thoracoscopy for Metastatic Osteosarcoma

Phase 3
Recruiting
Led By John J Doski
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon
Newly diagnosed patients 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 surgery
Must not have
Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment
Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days after surgical intervention
Awards & highlights

Summary

This trial compares the effect of open thoracic surgery to thoracoscopic surgery in treating patients with osteosarcoma that has spread to the lung.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include pain at the incision site(s), risk of infection, breathing difficulties post-surgery, and general risks associated with anesthesia and surgical procedures. Recovery time may also vary between the two types of surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung nodules can be surgically removed.
Select...
I have had or will have surgery to remove my primary tumor.
Select...
I have up to 4 lung nodules, each no larger than 3 cm, with at least one being at least 3 mm.
Select...
My diagnosis is osteosarcoma.
Select...
I am under 50 years old.
Select...
My lung cancer has spread from its original site.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had surgery on my lungs to remove cancer before joining this study.
Select...
My cancer has spread to my chest wall, mediastinum, or caused significant fluid around my lungs.
Select...
My cancer has spread beyond my lungs.
Select...
I have lung metastases needing major surgery or have central lung lesions.
Select...
My cancer has worsened in its original location or in the lungs while on my first treatment.
Select...
My primary tumor cannot be removed with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days after surgical intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days after surgical intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Thoracic event-free survival (tEFS)
Secondary study objectives
Event free survival (EFS)
Overall survival (OS)
Post operative pain interference at time point 3, 7-14 days after surgical intervention
+1 more
Other study objectives
Decision to change the post-operative treatment plan
Frequency of obtaining quality tumor tissue for biological analysis
Mode of tEFS event
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (thoracoscopy)Experimental Treatment3 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 Treatment4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thoracoscopy
2008
Completed Phase 3
~300
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Thoracotomy
2013
N/A
~620

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,580 Total Patients Enrolled
30 Trials studying Osteosarcoma
7,604 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,750 Total Patients Enrolled
104 Trials studying Osteosarcoma
16,378 Patients Enrolled for Osteosarcoma
John J DoskiPrincipal InvestigatorChildren's Oncology Group

Media Library

Thoracoscopy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05235165 — Phase 3
Osteosarcoma Research Study Groups: Arm A (thoracotomy), Arm B (thoracoscopy)
Osteosarcoma Clinical Trial 2023: Thoracoscopy Highlights & Side Effects. Trial Name: NCT05235165 — Phase 3
Thoracoscopy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05235165 — Phase 3
Osteosarcoma Patient Testimony for trial: Trial Name: NCT05235165 — Phase 3
~167 spots leftby Mar 2031
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