Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

Lung Metastases Clinical Trial

Official title:

The Efficacy of New Adjuvant Chemotherapy of Osteosarcoma Combined With Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932071
• Other study ID #: ChiCTR-IPR-16008568
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiaobo Yan, Dr.
• Phone: +8613588153306
• Email: yanxiaobo82[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Zoledronic acid is an adjuvant treatment for primary osteosarcoma. Zoledronic acid has been widely used in the treatment of metastatic bone tumors. In addition to its inhibition of tumor osteoclasis, it also produces certain killing of tumor cells. effect. Foreign studies have shown that zoledronic acid also has a killing effect on osteosarcoma and has a certain inhibitory effect on distant metastasis. We hope that it can reduce tumor recurrence and lung metastasis through this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with osteosarcoma who were diagnosed with initial pathology and pathology were excluded from lung metastasis or other metastatic lesions by CT and total body emission-computed tomography, and patients with standard chemotherapy were evaluated.

Exclusion Criteria:

• Pulmonary metastasis, pregnancy or lactation, renal insufficiency (creatinine clearance <70 ml/min/1.73 m2), liver dysfunction, obvious oral disease, and unsuitable for bisphosphonate treatment after evaluation, have been found. With diseases that still require hormone therapy, abnormal blood system, heart disease

Related Conditions & MeSH terms

• Lung Metastases
• Necrosis
• Osteosarcoma
• Tumor Necrosis

Intervention

Drug:
• Zoledronic Acid

Locations

Country	Name	City	State
China	2nd Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of lung metastasis	Discovery the rate of neonatal lung metastases by high-resolution chest CT	3 year
Primary	rate of tumor recurrence	Local recurrence rate of tumor or rate of distant metastasis	3 year
Secondary	rate of tumor necrosis less than 90%	the rate of patients that postoperative tumor necrosis rate was estimated to be lower than grade III(90%)	3 year