- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01917877
Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab
March 27, 2023 updated by: Qingdao Central Hospital
Phase II Study of Bevasizumab in the Management of Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: youxin ji, md
- Phone Number: 86532-68665078
- Email: ji6677@gmail.com
Study Locations
-
-
Shandong
-
Qingdao, Shandong, China, 266042
- Recruiting
- Qingdao Central Hospital
-
Contact:
- youxin ji, md
- Phone Number: 86-532-68665078
-
Principal Investigator:
- youxin ji, md
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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 Names:
|
Active Comparator: control
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
|
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pulmonary function
Time Frame: up to 8 weeks
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
thoracic CT scan
Time Frame: up to 8 weeks
|
up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2013
Primary Completion (Anticipated)
December 30, 2025
Study Completion (Anticipated)
December 30, 2025
Study Registration Dates
First Submitted
August 1, 2013
First Submitted That Met QC Criteria
August 6, 2013
First Posted (Estimate)
August 7, 2013
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Fibrosis
- Pulmonary Fibrosis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Bevacizumab
Other Study ID Numbers
- QCH-20030801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Fibrosis
-
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-
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