← Back to Search


Thoracotomy versus Thoracoscopic Management for Osteosarcoma

Phase 3
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
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 below
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.


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

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 more
Other outcome measures
Decision to change the post-operative treatment plan
Frequency of obtaining quality tumor tissue for biological analysis
Mode of tEFS event
+7 more

Awards & 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
Completed Phase 1
Computed Tomography
Completed Phase 2
Completed Phase 3

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

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

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?

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
~167 spots leftby Mar 2031