NCT00986284

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 22, 2015

Status Verified

August 1, 2012

Enrollment Period

7.2 years

First QC Date

September 27, 2009

Last Update Submit

December 21, 2015

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung CancerGefitinibNeoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    1 month

Study Arms (1)

Gefitinib, Neoadjuvant therapy

EXPERIMENTAL

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

Drug: gefitinib

Interventions

gefitinibDRUG

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.

Also known as: Iressa
Gefitinib, Neoadjuvant therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Changli Wang, MD

    Tianjin Medical University Cancer Institute and Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2009

First Posted

September 29, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 22, 2015

Record last verified: 2012-08

Locations

CN(1)