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Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

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ClinicalTrials.gov Identifier: NCT03932071
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. rate of lung metastasis [ Time Frame: 3 year ]
    Discovery the rate of neonatal lung metastases by high-resolution chest CT

  2. rate of tumor recurrence [ Time Frame: 3 year ]
    Local recurrence rate of tumor or rate of distant metastasis


Secondary Outcome Measures :
  1. 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%)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932071


Contacts
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Contact: Xiaobo Yan, Dr. +8613588153306 yanxiaobo82@gmail.com

Locations
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China, Zhejiang
2nd Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310020
Contact: Xiaobo Yan    13588153306    yanxiaobo82@gmail.com   
Principal Investigator: zhaoming Ye, Prof.         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: zhaoming Ye, Prof. 2nd Affiliated Hospital Of Zhejiang University

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Responsible Party: Zhaoming Ye, Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03932071     History of Changes
Other Study ID Numbers: ChiCTR-IPR-16008568
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Osteosarcoma
Necrosis
Neoplasms
Pathologic Processes
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs