search
Back to results

Bone Metastasis on the Survival of Gefitinib Effective Patients

Primary Purpose

Overal Survival, Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overal Survival, Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. histological and (or) cytological diagnosed NSCLC patients.
  2. patient was effective in Gefitinib treatment more than 6 months.
  3. whether patient received chemotherapy and other treatment is not restricted.
  4. whether patient was detected for EGFR gene mutation was not restricted.

Exclusion Criteria:

  1. patient with small cell lung cancer.
  2. patient without cytology or histopathology diagnosis results.
  3. patient with bone metastases cannot rule out other reasons such as inflammation or trauma.
  4. patient with poor treatment compliance.
  5. patient with incomplete data.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Gefitinib

    Arm Description

    Gefitinib is an selective small molecule epidermal growth factor receptors (EGFRs) tyrosine kinase inhibitors (EGFR-TKI) for non-small cell lung cancer.

    Outcomes

    Primary Outcome Measures

    Overal survival of patients
    The 5-year survival of NSCLC patients with or without bone metastasis

    Secondary Outcome Measures

    Survival of patients with both bone metastasis and brain metastasis
    Survival of patients with both bone metastasis and brain metastasis

    Full Information

    First Posted
    May 16, 2017
    Last Updated
    May 16, 2017
    Sponsor
    Qilu Hospital of Shandong University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03157310
    Brief Title
    Bone Metastasis on the Survival of Gefitinib Effective Patients
    Official Title
    Bone Metastasis on the Survival of Gefitinib Effective Patients With Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2009 (Actual)
    Primary Completion Date
    May 1, 2013 (Actual)
    Study Completion Date
    July 12, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qilu Hospital of Shandong University

    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
    Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.
    Detailed Description
    The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overal Survival, Non-small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    265 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gefitinib
    Arm Type
    Experimental
    Arm Description
    Gefitinib is an selective small molecule epidermal growth factor receptors (EGFRs) tyrosine kinase inhibitors (EGFR-TKI) for non-small cell lung cancer.
    Intervention Type
    Drug
    Intervention Name(s)
    Gefitinib
    Other Intervention Name(s)
    Iressa
    Intervention Description
    Daily oral administration of 250 mg Gefitinib
    Primary Outcome Measure Information:
    Title
    Overal survival of patients
    Description
    The 5-year survival of NSCLC patients with or without bone metastasis
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Survival of patients with both bone metastasis and brain metastasis
    Description
    Survival of patients with both bone metastasis and brain metastasis
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histological and (or) cytological diagnosed NSCLC patients. patient was effective in Gefitinib treatment more than 6 months. whether patient received chemotherapy and other treatment is not restricted. whether patient was detected for EGFR gene mutation was not restricted. Exclusion Criteria: patient with small cell lung cancer. patient without cytology or histopathology diagnosis results. patient with bone metastases cannot rule out other reasons such as inflammation or trauma. patient with poor treatment compliance. patient with incomplete data.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hai-Chun Liu, Dr.
    Organizational Affiliation
    Qilu Hospital of Shandong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The patients' data were not allowed to been using outside this research.

    Learn more about this trial

    Bone Metastasis on the Survival of Gefitinib Effective Patients

    We'll reach out to this number within 24 hrs