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OpenTrials
Completed

NCT Number: NCT04546243

Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study

According to EURAMOS-1, 17% of osteosarcoma patients were considered to have metastases at diagnosis. In this selected cohort, the reported 5-year EFS from diagnosis of 28% compares well to previous results reported from unselected cohorts of patients with only lung metastases. Resection of pulmonary metastases from osteosarcoma is a treatment option which has been shown to correlate with survival benefit and cure in select individuals. These patients are best addressed in a multidisciplinary fashion, with the involvement of a thoracic surgeon with experience in pulmonary metastasectomy. At the same time, the goal of surgical resection of pulmonary metastases from osteosarcoma is to render the patient completely disease free. "Tumor debulking" or "cytoreductive surgery" with incomplete resection has not demonstrated any survival benefit for patients with pulmonary metastases. Thus open thoracotomy is more preferred than VATS. However over the last decade in China, thoracotomy has not been adopted generally. More patients had chosen VATS or even hypo-fractionation radiotherapy, such as gamma knife, cyber knife and so on as a local treatment method. This study aims to investigate the survival of consecutive patients who had achieved a first complete surgical remission (CR) during combined-modality therapy on neoadjuvant or adjuvant PKUPH-OS protocol so as to discuss reasonable local therapy for resectable pulmonary osteosarcoma metastatic lesions.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed high-grade osteosarcoma reviewed by the Pathology Committee of Peking University People's Hospital
  • Pulmonary nodules by Chest CT confirmed by later scan as pulmonary metastasis
  • A first complete remission (CR) had been achieved
  • Intended first-line treatment included pre- and postoperative chemotherapy according to the PKUPH-OS protocol as well as local therapy of all operable lesions

Exclusion criteria

  • Lost to follow up
  • Patients with severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction<50%, and hypertension that could not be well controlled with antihypertensive drugs.

Treatment and study plan

resection group

Procedure

patients received VATS

radiotherapy group

Radiation

patients received radiotherapy

Primary outcomes

  1. event-free survival

    Time frame: 2 year

    from local therapy of the pulmonary nodules to any events of progression of disease/last follow-up

Secondary outcomes

  1. local recurrence rate

    Time frame: 2 year

    from local therapy of the pulmonary nodules to local recurrence/last follow-up

  2. overall survival

    Time frame: 5 year

    from local therapy of the pulmonary nodules to death/last follow-up

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Peking University Shougang Hospital

Registry information

Official study title

A Retrospective Study Investigating Survival for High-grade Osteosarcoma Patients Who Had Achieved First Complete Surgical Remission (SCR) During Combined-modality Therapy in Two Hospitals Affiliated to Peking University

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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