Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03932071

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Metastases Tumor Necrosis	Drug: Zoledronic Acid	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group	Drug: Zoledronic Acid
No Intervention: control group

Arm

Intervention/Treatment

Experimental: experimental group

Drug: Zoledronic Acid

No Intervention: control group

Outcome Measures

Primary Outcome Measures

rate of lung metastasis [3 year]
Discovery the rate of neonatal lung metastases by high-resolution chest CT
rate of tumor recurrence [3 year]
Local recurrence rate of tumor or rate of distant metastasis

Secondary Outcome Measures

rate of tumor necrosis less than 90% [3 year]
the rate of patients that postoperative tumor necrosis rate was estimated to be lower than grade III（90%）

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	China	310020

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Principal Investigator: zhaoming Ye, Prof., 2nd Affiliated Hospital Of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhaoming Ye, Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT03932071

Other Study ID Numbers:

ChiCTR-IPR-16008568

First Posted:

Apr 30, 2019

Last Update Posted:

May 6, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Osteosarcoma

Necrosis

Zoledronic Acid

Study Results

No Results Posted as of May 6, 2019