RecruitingPhase 3

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: CT scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To describe the relationship between the preoperative chest computed tomography (CT) imaging, intraoperative surgical findings, and pathologic results, comparing radiological features to the presence of viable tumor."
  • "To collect and bank pulmonary metastatic lesions (including frozen tissues and paired metastatic lesions coming from the same patient) to facilitate study of metastatic disease and serial blood samples for future tumor profiling, germline and circulating tumor deoxyribonucleic acid (DNA) studies."
  • "All patients undergo computed tomography (CT) throughout the trial."
  • "After completion of study treatment, patients are followed up at 7-14 days, 4-6 weeks, and 3 months post-surgery and then every 3 months for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two types of surgery for osteosarcoma, a bone cancer, that has spread to the lungs. One uses a large cut in the chest; the other uses small cuts and a camera. It is for people younger than 50 and aims to find out which surgery works better.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be younger than 50 and have osteosarcoma confirmed by a tissue test.
  • Each lung must have no more than 4 spots that may be cancer. At least one must be 3 millimeters or larger, and all must be 3 centimeters or smaller. A central team must review your scans.
  • Your surgeon must decide that the lung spots can be removed with either type of surgery.
  • Cancer must have spread to the lungs when first diagnosed, or when it first returns after treatment for cancer that had not spread.
  • If newly diagnosed, your main tumor must have been fully removed as far as the surgeon could see, or surgery to control it must be planned for the same time as lung surgery.
  • If newly diagnosed, you must be getting standard cancer drug treatment or have finished it within the past 60 days.
  • If cancer has returned for the first time, you must have finished standard cancer drug treatment for the original tumor. Drug or dose changes due to side effects are allowed.
  • You and/or your parent or legal guardian must sign a consent form. All required rules for research in people must be met.

Who can't join

  • Your main tumor cannot be removed by surgery.
  • Removing the lung spots would require removing a whole lung or a lung section called a lobe, or the spots are in or near major airway branches.
  • Cancer has spread to the chest wall or the space between the lungs, or you have a large amount of fluid around the lungs.
  • Cancer in the main tumor or lungs grew or spread during the first treatment. Small changes in spot size do not rule you out unless your care team decides the cancer truly got worse.
  • Cancer has spread to places other than the lungs.
  • You already had surgery to treat cancer that spread to the lungs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (220)

AK

AL

AR

AZ

CA

CO

CT

DC

DE

FL

GA

HI

  • Kapiolani Medical Center for Women and Children · Honolulu, HI 96826Site Public Contact · Study contact · 808-983-6090Wade T. Kyono · Principal investigatorMore trials in Honolulu

IA

ID

IL

IN

KY

LA

MA

  • Massachusetts General Hospital Cancer Center · Boston, MA 02114Site Public Contact · Study contact · 877-726-5130Danielle B. Cameron · Principal investigatorMore trials in Boston
  • Dana-Farber Cancer Institute · Boston, MA 02215Site Public Contact · Study contact · 877-442-3324Katherine A. Janeway · Principal investigatorMore trials in Boston

MD

ME

MI

MN

MO

MS

  • University of Mississippi Medical Center · Jackson, MS 39216Site Public Contact · Study contact · 601-815-6700Amanda Strobel · Principal investigatorMore trials in Jackson

NC

ND

NE

NH

NJ

NM

NV

NY

OH

OK

OR

PA

RI

SC

SD

TN

TX

UT

VA

VT

WA

WI

WV