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A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

Primary Purpose

Radiation-induced Lung Injury

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pirfenidone
basic treatment
Sponsored by
Beijing Continent Pharmaceutical Co, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation-induced Lung Injury focused on measuring pirfenidone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-75 years old (including 18 and 75 years);
  2. clinically diagnosed grade 2 or 3 radiation-induced lung injury;
  3. the course of radiation-induced lung injury is less than 2 months;
  4. ECOG 0-2;
  5. the expected survival time is more than 6 months;
  6. the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
  7. capable of eating solid food upon enrollment;
  8. subjects will voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

  1. have a history of chronic bronchial acute attack or severe pulmonary heart disease;
  2. pneumonectomy;
  3. tumor progression;
  4. severe pulmonary infection;
  5. creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;
  6. concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
  7. patients with active peptic ulcer;
  8. pregnant women and patients with mental illness;
  9. participating in clinical trials of other drugs within 3 months;
  10. the investigator determined that subject was not suitable.

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical Science
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pirfenidone

Controll

Arm Description

pirfenidone + basic treatment

with basic treatment and without pirfenidone treatment

Outcomes

Primary Outcome Measures

DLco% change
Compare DLco% from basement to the end of treatment

Secondary Outcome Measures

The grade change of radiation-induced lung injury
The score change of CT
Increase of effective lung volume
The grade change of Cough, Dyspnea and Fever

Full Information

First Posted
April 2, 2019
Last Updated
June 13, 2022
Sponsor
Beijing Continent Pharmaceutical Co, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03902509
Brief Title
A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Official Title
A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
The protocol revision is needed.
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Continent Pharmaceutical Co, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.
Detailed Description
The study is a randomized, controlled, multi-site clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-induced Lung Injury
Keywords
pirfenidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pirfenidone
Arm Type
Experimental
Arm Description
pirfenidone + basic treatment
Arm Title
Controll
Arm Type
Other
Arm Description
with basic treatment and without pirfenidone treatment
Intervention Type
Drug
Intervention Name(s)
Pirfenidone
Intervention Description
pirfenidone capsule made in China
Intervention Type
Drug
Intervention Name(s)
basic treatment
Intervention Description
glucocorticoid and expectant treatment etc.
Primary Outcome Measure Information:
Title
DLco% change
Description
Compare DLco% from basement to the end of treatment
Time Frame
Week 8 and 24
Secondary Outcome Measure Information:
Title
The grade change of radiation-induced lung injury
Time Frame
Week 8 and 24
Title
The score change of CT
Time Frame
Week 8 and 24
Title
Increase of effective lung volume
Time Frame
Week 8 and 24
Title
The grade change of Cough, Dyspnea and Fever
Time Frame
Week 8 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 years old (including 18 and 75 years); clinically diagnosed grade 2 or 3 radiation-induced lung injury; the course of radiation-induced lung injury is less than 2 months; ECOG 0-2; the expected survival time is more than 6 months; the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN capable of eating solid food upon enrollment; subjects will voluntarily participate in this study and sign the informed consent. Exclusion Criteria: have a history of chronic bronchial acute attack or severe pulmonary heart disease; pneumonectomy; tumor progression; severe pulmonary infection; creatinine clearance rate < 30ml/min, severe renal disease or need dialysis; concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study; patients with active peptic ulcer; pregnant women and patients with mental illness; participating in clinical trials of other drugs within 3 months; the investigator determined that subject was not suitable.
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

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