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

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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

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.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Drug: Bevacizumab Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bevasizumab in the Management of Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis
Study Start Date : August 2013
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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)

Active Comparator: control
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
Drug: Dexamethasone
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20




Primary Outcome Measures :
  1. pulmonary function [ Time Frame: up to 8 weeks ]

Secondary Outcome Measures :
  1. thoracic CT scan [ Time Frame: up to 8 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01917877


Contacts
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Contact: youxin ji, md 86532-68665078 ji6677@gmail.com

Locations
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China, Shandong
Qingdao Central Hospital Recruiting
Qingdao, Shandong, China, 266042
Contact: youxin ji, md    86-532-68665078      
Principal Investigator: youxin ji, md         
Sponsors and Collaborators
Qingdao Central Hospital
Investigators
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Principal Investigator: youxin ji, md Qingdao Central Hospital
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Responsible Party: Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT01917877    
Other Study ID Numbers: QCH-20030801
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: October 2015
Keywords provided by Qingdao Central Hospital:
Becacizumab
pulmonary fibrosis
irradiation
chemotherapy
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Dexamethasone
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal