Thoracoscopy for Osteosarcoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Osteosarcoma+3 More
Thoracoscopy - Procedure
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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
  • Metastatic Bone Sarcomas

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Osteosarcoma

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 24-48 hours after surgical intervention

Month 1
Frequency of obtaining quality tumor tissue for biological analysis
12 months after enrollment
Decision to change the post-operative treatment plan
Radiological features to the presence of viable tumor
Use of localization techniques
Hour 48
Post operative pain intensity at time point 2, 24-48 hours after surgical intervention
Post operative upper extremity function at time point 2, 24-48 hours after surgical intervention
Week 6
Post operative pain interference at time point 4, 4-6 weeks after surgical intervention
Day 14
Pain
Post operative pain interference at time point 3, 7-14 days after surgical intervention
Post operative upper extremity function at time point 3, 7-14 days after surgical intervention
At 30 days post-op
Perioperative surgical complications
Four years after enrollment
Event free survival (EFS)
Mode of tEFS event
Overall survival (OS)
Thoracic event-free survival (tEFS)
Month 12
Comparing radiological features to the presence of viable tumor
Therapeutic procedure

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Osteosarcoma

Trial Design

2 Treatment Groups

Arm A (thoracotomy)
1 of 2
Arm B (thoracoscopy)
1 of 2
Experimental Treatment

250 Total Participants · 2 Treatment Groups

Primary Treatment: Thoracoscopy · No Placebo Group · Phase 3

Arm A (thoracotomy)Experimental Group · 2 Interventions: Thoracotomy, Questionnaire Administration · Intervention Types: Procedure, Other
Arm B (thoracoscopy)Experimental Group · 2 Interventions: Questionnaire Administration, Thoracoscopy · Intervention Types: Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thoracotomy
2013
N/A
~620
Thoracoscopy
2008
Completed Phase 3
~300

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24-48 hours after surgical intervention

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,989 Previous Clinical Trials
41,298,808 Total Patients Enrolled
99 Trials studying Osteosarcoma
18,773 Patients Enrolled for Osteosarcoma
Children's Oncology GroupLead Sponsor
446 Previous Clinical Trials
234,840 Total Patients Enrolled
30 Trials studying Osteosarcoma
11,100 Patients Enrolled for Osteosarcoma
John J DoskiPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age < 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
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.
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.
Patients must have a histological diagnosis of osteosarcoma.
You have previously completed systemic therapy for your primary tumor.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.