Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Survival, Osteosarcoma Metastatic, Pulmonary Disease, Resectable Sarcoma

Intervention / Treatment
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* Procedure: resection group
* Radiation: radiotherapy group


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| osteosarcoma patients receiving resections<br> | Procedure: resection group<br>* patients received VATS<br>|
| osteosarcoma patients receiving radiotherapy<br> | Radiation: radiotherapy group<br>* patients received radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event-free survival | from local therapy of the pulmonary nodules to any events of progression of disease/last follow-up | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence rate | from local therapy of the pulmonary nodules to local recurrence/last follow-up | 2 year | 
| overall survival | from local therapy of the pulmonary nodules to death/last follow-up | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteosarcoma, pulmonary metastasis, resectable, event-free survival