Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study

Pulmonary Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546243
• Other study ID #: PKUPH-sarcoma 13
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2020
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteosarcoma
• Osteosarcoma Metastatic
• Pulmonary Disease
• Resectable Sarcoma
• Survival

Intervention

Procedure:
• resection group
patients received VATS

Radiation:
• radiotherapy group
patients received radiotherapy

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Peking University Shougang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event-free survival	from local therapy of the pulmonary nodules to any events of progression of disease/last follow-up	2 year
Secondary	local recurrence rate	from local therapy of the pulmonary nodules to local recurrence/last follow-up	2 year
Secondary	overall survival	from local therapy of the pulmonary nodules to death/last follow-up	5 year