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

NCT ID: NCT00986284

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-11-30

Brief Summary

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This study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage IIIA NSCLC patients.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Keywords

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Non Small Cell Lung Cancer Gefitinib Neoadjuvant Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gefitinib, Neoadjuvant therapy

Patients with EGFR mutation will be recruited and treated with gefitinib.

Group Type EXPERIMENTAL

gefitinib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Iressa

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Changli Wang, MD

Role: STUDY_DIRECTOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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TMU-CIH-LCC-001

Identifier Type: -

Identifier Source: org_study_id