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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

  • Clinicaltrials.gov identifier

    NCT03932071

  • Recruitment Status

    Recruiting

  • First Posted

    April 30, 2019

  • Last update posted

    May 6, 2019

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:Tumor Necrosis
    Lung Metastases
  • Intervention/Treatment: Drug: Zoledronic Acid
  • Phase: Phase 4

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2017
  • Estimated Primary Completion Date: January 2020
  • Estimated Study Completion Date: January 2023

Arms and interventions

Arm Intervention/treatment
Experimental: experimental group
Drug: Zoledronic Acid

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

  • 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

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

Locations

China, Zhejiang
2nd Affiliated Hospital of Zhejiang University
Hangzhou

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

More Information

  • Responsible Party: 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
  • 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: Osteosarcoma Necrosis