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RecruitingLast updated: 25 February 2026

AOST2031: This trial is evaluating two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is more effectiveA Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Sarcoma Cancers Sarcoma

Age

People0 - 50

Trial acronym

AOST2031

Clinical summary

Summary

Eligible participants will be randomly allocated (by chance) to one of two arms.

In Arm A, participants will undergo open thoracic surgery (thoracotomy). This surgery is done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer.

In Arm B, participants will undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). This is where the doctors makes several small incisions and uses a small camera to help with removing the cancer.

All participants will undergo computed tomography (CT) throughout the trial. Participants may also undergo collection of tissue on study and blood throughout the trial.

After completion of the study treatment, participants are followed up at 7-14 days, 4-6 weeks, and 3 months post-surgery, and then every 3 months fo rup to 2 years.

Conditions

This trial is treating people with osteosarcoma that has spread to the lung

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Children's Oncology Group

Scientific Title

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

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