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

Primary Purpose

Pulmonary Fibrosis

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Bevacizumab

Dexamethasone

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Becacizumab, pulmonary fibrosis, irradiation, chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Qingdao Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

control

Arm Description

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

Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

Outcomes

Primary Outcome Measures

pulmonary function

Secondary Outcome Measures

thoracic CT scan

Full Information

NCT ID

NCT01917877

First Posted

August 1, 2013

Last Updated

March 27, 2023

Sponsor

Qingdao Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01917877

Brief Title

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

Official Title

Phase II Study of Bevasizumab in the Management of Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2013 (Actual)

Primary Completion Date

December 30, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qingdao Central Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Fibrosis

Keywords

Becacizumab, pulmonary fibrosis, irradiation, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

Active Comparator

Arm Description

Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin (Genentech/Roche)

Intervention Description

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 Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20

Primary Outcome Measure Information:

Title

pulmonary function

Time Frame

up to 8 weeks

Secondary Outcome Measure Information:

Title

thoracic CT scan

Time Frame

up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

youxin ji, md

Phone

86532-68665078

ji6677@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

youxin ji, md

Organizational Affiliation

Qingdao Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qingdao Central Hospital

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

youxin ji, md

Phone

86-532-68665078

First Name & Middle Initial & Last Name & Degree

youxin ji, md

12. IPD Sharing Statement

Learn more about this trial

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

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