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NCT Number: NCT03157310

Bone Metastasis on the Survival of Gefitinib Effective Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Gefitinib

Drug

Daily oral administration of 250 mg Gefitinib

Other names: Iressa

Primary outcomes

  1. Overal survival of patients

    Time frame: 5 years

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

Secondary outcomes

  1. Survival of patients with both bone metastasis and brain metastasis

    Time frame: 3 years

    Survival of patients with both bone metastasis and brain metastasis

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
May 17, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.