NCT02296281

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1.4 years

First QC Date

November 18, 2014

Last Update Submit

November 19, 2014

Conditions

Radiation Pneumonitis

Outcome Measures

Primary Outcomes (1)

  • Changes in radiation-induced lung injury classification

    36 Weeks

Study Arms (1)

treatment group

EXPERIMENTAL
Drug: Pirfenidone

Interventions

PirfenidoneDRUG
treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiation Pneumonitis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryRadiation InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Last Updated

November 20, 2014

Record last verified: 2014-11