Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01917877
Recruitment Status : Unknown
Verified October 2015 by Qingdao Central Hospital.
Recruitment status was:  Recruiting
First Posted : August 7, 2013
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Qingdao Central Hospital

Tracking Information
First Submitted Date  ICMJE August 1, 2013
First Posted Date  ICMJE August 7, 2013
Last Update Posted Date February 14, 2018
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
pulmonary function [ Time Frame: up to 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
thoracic CT scan [ Time Frame: up to 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab
Official Title  ICMJE Phase II Study of Bevasizumab in the Management of Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis
Brief Summary Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not only compromise cancer treatment, but also influence patient's life qualities and even death. there are no specific treatment modalities for this treatment-induced complication. Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by Dexamethasone (10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone. The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30 cases.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: Bevacizumab
    Bevacizumab 7mg/kg iv on day1 and 21, followed by Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
    Other Name: Avastin (Genentech/Roche)
  • Drug: Dexamethasone
    Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
Study Arms  ICMJE
  • Experimental: study group
    Bevacizumab 7mg/kg iv on day1 and 21, followed by Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
    Intervention: Drug: Bevacizumab
  • Active Comparator: control
    Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
    Intervention: Drug: Dexamethasone
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 6, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

Exclusion Criteria:

  • chronic pulmonary fibrosis and infection-induced pulmonary fibrosis
  • active bleeding
  • uncontrolled high blood pressure
  • unstable systemic disease
  • prior exposure to VEGF inhibitor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01917877
Other Study ID Numbers  ICMJE QCH-20030801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qingdao Central Hospital
Study Sponsor  ICMJE Qingdao Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: youxin ji, md Qingdao Central Hospital
PRS Account Qingdao Central Hospital
Verification Date October 2015

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