Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04546243
Other study ID # PKUPH-sarcoma 13
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Terminated NCT03309358 - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis Phase 1
Active, not recruiting NCT02504697 - DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Completed NCT00210249 - Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
Completed NCT00023114 - p450 Mediated Lung Toxicity N/A
Recruiting NCT06056882 - Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
Completed NCT03994848 - Incentive Spirometry Prehabilitation Study N/A
Completed NCT00366509 - Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
Withdrawn NCT05100160 - Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial) Phase 3
Completed NCT03229473 - Fall Risk Assessment in COPD
Recruiting NCT04767074 - A Non-pharmacological Cough Control Therapy N/A
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04996693 - On Dose Efficiency of Modern CT-scanners in Chest Scans N/A
Recruiting NCT04996173 - Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis) N/A
Completed NCT04601545 - The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method N/A
Recruiting NCT03937583 - Screening for Cancer in Patients With Unprovoked VTE Phase 4
Recruiting NCT02862418 - Imaging of Lungs With a New Type of Magnetic Resonance Imaging (MRI) Called UTE (Ultrashort Echo Time)