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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

No Placebo-Only Group

Pivotal Trial

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

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My lung nodules can be surgically removed.

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I have had or will have surgery to remove my primary tumor.

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I have up to 4 lung nodules, each no larger than 3 cm, with at least one being at least 3 mm.

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My diagnosis is osteosarcoma.

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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:

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I had surgery on my lungs to remove cancer before joining this study.

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My cancer has spread to my chest wall, mediastinum, or caused significant fluid around my lungs.

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My cancer has spread beyond my lungs.

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I have lung metastases needing major surgery or have central lung lesions.

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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 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

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

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.

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

~2030