- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03932071
Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
May 2, 2019 updated by: Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University
The Efficacy of New Adjuvant Chemotherapy of Osteosarcoma Combined With Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaobo Yan, Dr.
- Phone Number: +8613588153306
- Email: yanxiaobo82@gmail.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310020
- Recruiting
- 2nd Affiliated Hospital of Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
|
|
No Intervention: control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of lung metastasis
Time Frame: 3 year
|
Discovery the rate of neonatal lung metastases by high-resolution chest CT
|
3 year
|
rate of tumor recurrence
Time Frame: 3 year
|
Local recurrence rate of tumor or rate of distant metastasis
|
3 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of tumor necrosis less than 90%
Time Frame: 3 year
|
the rate of patients that postoperative tumor necrosis rate was estimated to be lower than grade III(90%)
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
April 26, 2019
First Submitted That Met QC Criteria
April 26, 2019
First Posted (Actual)
April 30, 2019
Study Record Updates
Last Update Posted (Actual)
May 6, 2019
Last Update Submitted That Met QC Criteria
May 2, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChiCTR-IPR-16008568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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