Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Description

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.

Conditions

Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma

Study Overview

Study Details

Study overview

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.

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Condition
Metastatic Malignant Neoplasm in the Lung
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's Hospital of Alabama, Birmingham, Alabama, United States, 35233

Anchorage

Providence Alaska Medical Center, Anchorage, Alaska, United States, 99508

Kingman

Kingman Regional Medical Center, Kingman, Arizona, United States, 86401

Mesa

Banner Children's at Desert, Mesa, Arizona, United States, 85202

Phoenix

Phoenix Childrens Hospital, Phoenix, Arizona, United States, 85016

Tucson

Banner University Medical Center - Tucson, Tucson, Arizona, United States, 85719

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202-3591

Anaheim

Kaiser Permanente-Anaheim, Anaheim, California, United States, 92806

Arroyo Grande

PCR Oncology, Arroyo Grande, California, United States, 93420

Bellflower

Kaiser Permanente-Bellflower, Bellflower, California, United States, 90706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Patients must have a histological diagnosis of osteosarcoma.
  • * Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
  • * Patients with newly diagnosed disease 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.
  • * Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
  • * Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
  • * 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.
  • * Patients with evidence of extrapulmonary metastatic disease.
  • * Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
  • * All patients and/or their parents or legal guardians must sign a written informed consent.
  • * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Ages Eligible for Study

to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Oncology Group,

John J Doski, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

2031-03-31