Bone Metastasis on the Survival of Gefitinib Effective Patients

NCT03157310 | Completed

• 1 other identifier: 2017-QLH-11
• Study Type: interventional
• Target: 265
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overal Survival, Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overal survival of patients

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

  5 years

Secondary Outcomes (1)

• Survival of patients with both bone metastasis and brain metastasis

  3 years

Study Arms (1)

Gefitinib

EXPERIMENTAL

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

Drug: Gefitinib

Interventions

Gefitinib DRUG

Daily oral administration of 250 mg Gefitinib

Also known as: Iressa

Gefitinib

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hai-Chun Liu, Dr.

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: July 12, 2015
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share