Pediatric Clinical Trials

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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.

Stanford is currently accepting patients for this trial.

Intervention(s):

  • procedure: Biospecimen Collection
  • procedure: Computed Tomography
  • other: Questionnaire Administration
  • procedure: Thoracoscopy
  • procedure: Thoracotomy

Eligibility


Inclusion 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.

Exclusion Criteria:

   - 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

N/A - 50 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chloe Anne Lontoc Ordona
cordona@stanford.edu
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