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出境医 / 临床实验 / Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

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
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: experimental group Drug: Zoledronic Acid
No Intervention: control group
Outcome Measures
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%）


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • rate of lung metastasis [ Time Frame: 3 year ]
    Discovery the rate of neonatal lung metastases by high-resolution chest CT
  • rate of tumor recurrence [ Time Frame: 3 year ]
    Local recurrence rate of tumor or rate of distant metastasis
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • lung metastasis [ Time Frame: 3 year ]
  • tumor recurrence [ Time Frame: 3 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019) 		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%）
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • tumor necrosis less than 90% [ Time Frame: 3 year ]
  • the patients request to quit [ Time Frame: 3 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
Official Title  ICMJE The Efficacy of New Adjuvant Chemotherapy of Osteosarcoma Combined With Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Lung Metastases
  • Tumor Necrosis
Intervention  ICMJE Drug: Zoledronic Acid
Study Arms  ICMJE
  • Experimental: experimental group
    Intervention: Drug: Zoledronic Acid
  • No Intervention: control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaobo Yan, Dr. +8613588153306 yanxiaobo82@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932071
Other Study ID Numbers  ICMJE ChiCTR-IPR-16008568
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: zhaoming Ye, Prof. 2nd Affiliated Hospital Of Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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