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Bone Metastasis on the Survival of Gefitinib Effective Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03157310
Enrollment
265
Registered
2017-05-17
Start date
2009-05-01
Completion date
2015-07-12
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overal Survival, Non-small Cell Lung Cancer

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.

Interventions

DRUGGefitinib

Daily oral administration of 250 mg Gefitinib

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overal survival of patients5 yearsThe 5-year survival of NSCLC patients with or without bone metastasis

Secondary

MeasureTime frameDescription
Survival of patients with both bone metastasis and brain metastasis3 yearsSurvival of patients with both bone metastasis and brain metastasis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026