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Procedure
Thoracotomy versus Thoracoscopic Management for 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
Patients must have =< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being >= 3 mm and all of which must be =< 3 cm size.
Patients must have a histological diagnosis of osteosarcoma.
Must not have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up7-14 days after surgical intervention
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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.
Eligible Conditions
- Osteosarcoma
- Lung Cancer
- Bone Sarcoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have evidence of metastatic disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
Select...
You are receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
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 moreAwards & Highlights
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.
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
Biospecimen Collection
2004
Completed Phase 1
~1670
Computed Tomography
2017
Completed Phase 2
~2890
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
452 Previous Clinical Trials
236,901 Total Patients Enrolled
31 Trials studying Osteosarcoma
12,342 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)NIH
13,492 Previous Clinical Trials
41,267,331 Total Patients Enrolled
104 Trials studying Osteosarcoma
21,106 Patients Enrolled for Osteosarcoma
John J DoskiPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a primary tumor that cannot be removed by surgery.You have metastatic lung cancer that is located in a part of the lung that would require surgery to remove or is located near the center of the lung.You had surgery to remove lung metastasis before joining the study.Patients must be < 50 years at the time of enrollment.You have lung nodules that are considered resectable by either open thoracotomy or thoracoscopic surgery.You have evidence of metastatic disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.You are receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
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
How many prior treatments have patients received?
0
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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