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

About this trial
This is an interventional treatment trial for Overal Survival, Non-small Cell Lung Cancer
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.
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
NCT ID
NCT03157310
First Posted
May 16, 2017
Last Updated
May 16, 2017
Sponsor
Qilu Hospital of Shandong University
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
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