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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days after surgical intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-14 days after surgical intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days after surgical intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Thoracic event-free survival (tEFS)
Secondary outcome measures
Event free survival (EFS)
Overall survival (OS)
Post operative pain interference at time point 3, 7-14 days after surgical intervention
+1 moreOther outcome measures
Decision to change the post-operative treatment plan
Frequency of obtaining quality tumor tissue for biological analysis
Mode of tEFS event
+7 moreTrial 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
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Thoracoscopy
2008
Completed Phase 3
~300
Thoracotomy
2013
N/A
~620
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,690 Total Patients Enrolled
30 Trials studying Osteosarcoma
7,604 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,883 Total Patients Enrolled
103 Trials studying Osteosarcoma
16,324 Patients Enrolled for Osteosarcoma
John J DoskiPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung nodules can be surgically removed.I had surgery on my lungs to remove cancer before joining this study.My lung nodules can be surgically removed.I have had or will have surgery to remove my primary tumor.My cancer has spread to my chest wall, mediastinum, or caused significant fluid around my lungs.My lung cancer has spread from its original site.My cancer has spread beyond my lungs.I have up to 4 lung nodules, each no larger than 3 cm, with at least one being at least 3 mm.My diagnosis is osteosarcoma.My diagnosis is osteosarcoma.I have recently started or finished standard treatment for newly diagnosed osteosarcoma.I have lung metastases needing major surgery or have central lung lesions.I am under 50 years old.I completed standard treatment for my initial osteosarcoma before its first recurrence.My lung cancer has spread from its original site.My cancer has worsened in its original location or in the lungs while on my first treatment.I have up to 4 lung nodules, each no larger than 3 cm, with at least one being at least 3 mm.My primary tumor cannot be removed with surgery.I am under 50 years old.I am newly diagnosed and my treatment is as strong as or stronger than MAP.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (thoracotomy)
- Group 2: Arm B (thoracoscopy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteosarcoma Patient Testimony for trial: Trial Name: NCT05235165 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators still signing up volunteers for this research project?
"This trial is currently looking for patients. The original posting date was February 15th, 2022 and the most recent update was on October 19th, 2022."
Answered by AI
How many volunteers are being chosen for this opportunity?
"The most recent information available on clinicaltrials.gov indicates that this study is still recruiting patients. This trial was first posted on February 15th, 2022 and was last updated on October 19th, 2022. The goal is to enroll 250 participants from 100 different locations."
Answered by AI
Is Thoracoscopy a high-risk procedure for patients?
"Thoracoscopy is classified as a safe medical procedure because it has received a score of 3. This means that multiple rounds of clinical trials have found it to be both effective and safe."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
IWK Health Centre
Why did patients apply to this trial?
I want to help my husband who has been diagnosed with oscrsarcoma it has spread to his lymph nodes and reqlly want information om anything to help him please many thanks tina biles x.
PatientReceived 1 prior treatment
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