NCT04546243

Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study

Completed Last updated 4 December 2020

What this trial tests

trial testing resection group in Osteosarcoma Metastatic in 127 participants. Completed in 1 November 2020.

Timeline

1 January 2020

Primary endpoint
1 October 2020

1 November 2020

Quick facts

Lead sponsor	Peking University People's Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	127
Start date	1 January 2020
Primary completion	1 October 2020
Estimated completion	1 November 2020
Sites	2 locations across China

Drugs / interventions tested

• resection group
• radiotherapy group

Conditions studied

• Osteosarcoma Metastatic — all drugs for Osteosarcoma Metastatic →
• Pulmonary Disease — all drugs for Pulmonary Disease →
• Resectable Sarcoma — all drugs for Resectable Sarcoma →
• Survival — all drugs for Survival →

Sponsor

Peking University People's Hospital

Who can join

Eligibility, any sex, with Osteosarcoma Metastatic or Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Complete remission of metastatic osteosarcoma using combined modality therapy: a retrospective analysis of unselected patients in China.
   Xie L, Xu J, Li X, Zhou Z, et al · · 2021 · cited 5× · PMID 33789614 · DOI 10.1186/s12885-021-08071-5