Back to resultsZoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
Primary Purpose
Lung Metastases, Tumor Necrosis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Lung Metastases
Eligibility Criteria
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
Sites / Locations
- 2nd Affiliated Hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
Outcomes
Primary Outcome Measures
rate of lung metastasis
Discovery the rate of neonatal lung metastases by high-resolution chest CT
rate of tumor recurrence
Local recurrence rate of tumor or rate of distant metastasis
Secondary Outcome Measures
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%）
Full Information
NCT ID
NCT03932071
First Posted
April 26, 2019
Last Updated
May 2, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03932071
Brief Title
Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
Official Title
The Efficacy of New Adjuvant Chemotherapy of Osteosarcoma Combined With Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Metastases, Tumor Necrosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Primary Outcome Measure Information:
Title
rate of lung metastasis
Description
Discovery the rate of neonatal lung metastases by high-resolution chest CT
Time Frame
3 year
Title
rate of tumor recurrence
Description
Local recurrence rate of tumor or rate of distant metastasis
Time Frame
3 year
Secondary Outcome Measure Information:
Title
rate of tumor necrosis less than 90%
Description
the rate of patients that postoperative tumor necrosis rate was estimated to be lower than grade III（90%）
Time Frame
3 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobo Yan, Dr.
Phone
+8613588153306
Email
yanxiaobo82@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhaoming Ye, Prof.
Organizational Affiliation
2nd Affiliated Hospital Of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobo Yan
Phone
13588153306
Email
yanxiaobo82@gmail.com
First Name & Middle Initial & Last Name & Degree
zhaoming Ye, Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
We'll reach out to this number within 24 hrs