Grants and Contracts Details
Description
Abstract
Patients with osteosarcoma typically receive a combination of systemic therapy and surgical
control of the primary tumor site. Surgical control of pulmonary metastases, the most common
site of metastasis for patients with osteosarcoma, is also considered necessary for long term
survival. Surgical resection via open surgery (thoracotomy or sternotomy) has been the mainstay
of surgical management, and allows for identification, localization, and resection of all metastatic
disease.
With the advent of minimally invasive surgery, thoracoscopy is now applied to all aspects of chest
pathology including cancer operations. The benefits of thoracoscopy include faster patient
recovery and healing times, and improved quality of life. While thoracoscopy limits the use of
haptic sense achieved by palpation of tissue, randomized controlled trials for adult patients with
non-small cell lung cancer have not identified thoracotomy or sternotomy to be superior to
thoracoscopy in thoracic event rates. Data for thoracoscopic surgery in pulmonary metastatic
osteosarcoma are limited to retrospective reports.1
This study will be the first randomized controlled trial of surgical approach for pulmonary
metastatic osteosarcoma. This study will reduce pulmonary disease heterogeneity by only
enrolling patients with 4 or fewer CT identified nodules per lung (henceforth referred to as
“oligometastatic”), and preoperative chest CTs will receive central radiologic review to confirm
eligibility. Enrolled patients will be stratified by disease status at time of enrollment (newly
diagnosed and recurrent disease), each further characterized by risk (considered average and
poor) on the basis of the number of pulmonary nodules (1 vs ≥ 2), site of pulmonary nodules
(unilateral vs. bilateral), and primary tumor histological response to chemotherapy for newly
diagnosed patients (< 10% or > 10% viable tumor in resected specimen). Patients with recurrent
disease will also be stratified by the treating oncologists’ intent to treat with chemotherapy for
recurrence (yes vs. no). Primary outcome will be thoracic event free survival (thoracic event is
defined as intrathoracic tumor recurrence by chest CT or death that results from the procedure or
a complication related to the procedure). Correlative outcomes include quality of life from patient-
reported outcomes, along with imaging and laboratory studies.
Status | Finished |
---|---|
Effective start/end date | 3/1/21 → 7/31/24 |
Funding
- Public Health Institute: $2.00
Fingerprint
Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.