Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study

Completed

• Conditions: Pulmonary Disease; Resectable Sarcoma; Survival; Osteosarcoma Metastatic
• Interventions: Procedure: resection group; Radiation: radiotherapy group

• Registration Number: NCT04546243
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-06
• Study First Posted: 2020-09-11
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
osteosarcoma patients receiving resections	resection group	-
osteosarcoma patients receiving radiotherapy	radiotherapy group	-

Primary Outcome Measures

Name	Time	Method
event-free survival	2 year	from local therapy of the pulmonary nodules to any events of progression of disease/last follow-up

Secondary Outcome Measures

Name	Time	Method
local recurrence rate	2 year	from local therapy of the pulmonary nodules to local recurrence/last follow-up
overall survival	5 year	from local therapy of the pulmonary nodules to death/last follow-up

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, Beijing, China