Bone Metastasis on the Survival of Gefitinib Effective Patients

Not Applicable

Completed

• Conditions: Overal Survival, Non-small Cell Lung Cancer
• Interventions: Drug: Gefitinib

• Registration Number: NCT03157310
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Study Timeline

• Study Start: 2009-05-01
• Primary Completion: 2013-05-01
• Study Completion: 2015-07-12
• Status Verified: 2017-05
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overal survival of patients	5 years	The 5-year survival of NSCLC patients with or without bone metastasis

Secondary Outcome Measures

Name	Time	Method
Survival of patients with both bone metastasis and brain metastasis	3 years	Survival of patients with both bone metastasis and brain metastasis