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Epidermal Growth Factor Receptor (EGFR) Status Based Gefitinib Neoadjuvant Therapy in Non Small Cell Lung Cancer (NSCLC)

This study has suspended participant recruitment.
(Lack of patients and some progressed disease soon after surgery)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00986284
First Posted: September 29, 2009
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
  Purpose
This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: gefitinib Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of EGFR Status Based Gefitinib Neoadjuvant Therapy in NSCLC Patients

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 1 month ]

Enrollment: 102
Study Start Date: September 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib, Neoadjuvant therapy
Patients with EGFR mutation will be recruited and treated with gefitinib.
Drug: gefitinib
Patients with EGFR mutation in exon 19 or 21 will be administrated with gefitinib as neoadjuvant therapy. Then evaluated for response and then operation for operable patients.
Other Name: Iressa

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
  • Stage IIIA patients with technical operable disease evaluated by image and lab results;
  • Patients without chemotherapy or targeted-therapy before;
  • Inform Consent.

Exclusion Criteria:

  • Patients with malignant tumor other than lung cancer;
  • Patients with other diseases such as cardiovascular disease that may hamper follow up;
  • Patients that may not coordinate well,judged by researcher.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986284


Locations
China, Tianjin
Tianjin Cancer Institute & Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Director: Changli Wang, MD Tianjin Medical University Cancer Institute and Hospital
  More Information

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT00986284     History of Changes
Other Study ID Numbers: TMU-CIH-LCC-001
First Submitted: September 27, 2009
First Posted: September 29, 2009
Last Update Posted: December 22, 2015
Last Verified: August 2012

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Non Small Cell Lung Cancer
Gefitinib
Neoadjuvant Therapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action