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Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

Primary Purpose

Radiation Pneumonitis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pirfenidone
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 Pneumonitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-70 years old (include 18 and 70 years), male or female
  2. The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
  3. General condition assessment, ECOG score of 0-1
  4. Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
  5. The expected survival at 6 months or more
  6. Subject is able to eat solid food
  7. The initial radical thoracic radiotherapy treatment
  8. The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
  9. The duration of radiation-induced lung injury in less than 1 month
  10. Signed informed consent

Exclusion Criteria:

  1. Radiation-induced lung injury has entered the chronic phase
  2. A history of chronic bronchitis, emphysema, or a history of cor pulmonale
  3. Lung resection surgery
  4. Cancer progression
  5. Pulmonary infection
  6. Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
  7. With active peptic ulcer
  8. Pregnant women and patients with mental disease
  9. Those who participate in clinical trials of other drugs within 3 months
  10. Investigator judge does not apply to participate in the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes in radiation-induced lung injury classification

    Secondary Outcome Measures

    Full Information

    First Posted
    November 18, 2014
    Last Updated
    November 19, 2014
    Sponsor
    Beijing Continent Pharmaceutical Co, Ltd.
    Collaborators
    Shanghai Genomics, Inc., GNI-EPS Pharmaceuticals, Inc. (GNI Group)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02296281
    Brief Title
    Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Continent Pharmaceutical Co, Ltd.
    Collaborators
    Shanghai Genomics, Inc., GNI-EPS Pharmaceuticals, Inc. (GNI Group)

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Pirfenidone
    Primary Outcome Measure Information:
    Title
    Changes in radiation-induced lung injury classification
    Time Frame
    36 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-70 years old (include 18 and 70 years), male or female The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline General condition assessment, ECOG score of 0-1 Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L The expected survival at 6 months or more Subject is able to eat solid food The initial radical thoracic radiotherapy treatment The clinical diagnosis of radiation-induced lung injury in Grade 2 or above The duration of radiation-induced lung injury in less than 1 month Signed informed consent Exclusion Criteria: Radiation-induced lung injury has entered the chronic phase A history of chronic bronchitis, emphysema, or a history of cor pulmonale Lung resection surgery Cancer progression Pulmonary infection Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc. With active peptic ulcer Pregnant women and patients with mental disease Those who participate in clinical trials of other drugs within 3 months Investigator judge does not apply to participate in the trial

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

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