Health Trials

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

ConditionsMetastatic Malignant Neoplasm in the LungMetastatic OsteosarcomaOsteosarcoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 50
SponsorChildren's Oncology Group

About this trial

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be < 50 years at the time of enrollment.

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.

Note: Patient must have eligibility confirmed by rapid central imaging review.

Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.

Disqualifiers

Patients with unresectable primary tumor.

Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).

Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.

Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of tissue and blood

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Thoracoscopy

    Procedure/Surgery

    Undergo video-assisted thoracoscopic surgery or VATS

  • Thoracotomy

    Procedure/Surgery

    Undergo open thoracic surgery

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Arm A (thoracotomy)Experimental treatment 4 interventions
Group B: Arm B (thoracoscopy)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Thoracic event-free survival (tEFS)

Estimated four year thoracic event free survival (tEFS) where tEFS is calculated as the time from study enrollment to thoracic cavity event. Any recurrence within the pulmonary parenchyma, involving the pleural surface or the drain/surgical site wound will be considered an event. A death that results from the procedure, as confirmed by the treating physician, will be considered an event. Patients with recurrences arising outside the thoracic region, the diagnosis of a malignancy that is not osteosarcoma (SMN) or death considered unrelated to the study surgical procedure, as confirmed by the treating physician will be considered competing events provided these occur prior to a thoracic cavity event as defined above. Patients without an event of any kind at last contact are considered censored.

Time frame
Four years after enrollment

Secondary outcomes

1

Event free survival (EFS)

Estimated four year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Patients without an event at last contact are considered censored.

Time frame
Four years after enrollment
2

Overall survival (OS)

Time from study enrollment to death or last patient contact. Patients alive at last contact are considered censored.

Time frame
Four years after enrollment

Other outcomes

1

Perioperative surgical complications

The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be utilized for AE reporting.

Time frame
At 30 days post-op
2

Mode of tEFS event

Classified as: (1) ipsilateral recurrence site; (2) contralateral recurrence site; or (3) ipsilateral and contralateral recurrence site. The analysis will be restricted to patients with unilateral disease at enrollment.

Time frame
Four years after enrollment
3

Use of localization techniques

Data collection will include a description of all localization methods used.

Time frame
12 months after enrollment
4

Decision to change the post-operative treatment plan

Whether the investigator adhered to the post-thoracic surgery plan for systemic therapy.

Time frame
12 months after enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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