Bone Metastasis on the Survival of Gefitinib Effective Patients

Overal Survival, Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157310
• Other study ID #: 2017-QLH-11
• Status: Completed
• Phase: N/A
• First received: May 16, 2017
• Last updated: May 16, 2017
• Start date: May 1, 2009
• Est. completion date: July 12, 2015

Study information

• Verified date: May 2017
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: July 12, 2015
• Est. primary completion date: May 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Overal Survival, Non-small Cell Lung Cancer

Intervention

Drug:
• Gefitinib
Daily oral administration of 250 mg Gefitinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overal survival of patients	The 5-year survival of NSCLC patients with or without bone metastasis	5 years
Secondary	Survival of patients with both bone metastasis and brain metastasis	Survival of patients with both bone metastasis and brain metastasis	3 years