Bone Metastasis on the Survival of Gefitinib Effective Patients

Bone Metastasis on the Survival of Gefitinib Effective Patients With Non-small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Overal Survival, Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Gefitinib

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.

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gefitinib; Gefitinib is an selective small molecule epidermal growth factor receptors (EGFRs) tyrosine kinase inhibitors (EGFR-TKI) for non-small cell lung cancer.	Drug: Gefitinib; Daily oral administration of 250 mg Gefitinib; Other Names: Iressa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overal survival of patients	The 5-year survival of NSCLC patients with or without bone metastasis	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of patients with both bone metastasis and brain metastasis	Survival of patients with both bone metastasis and brain metastasis	3 years

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Hai-Chun Liu, Dr., Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 12, 2015

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: 2017-QLH-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patients' data were not allowed to been using outside this research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No