Epidermal Growth Factor Receptor (EGFR) Status Based Gefi... | NCT00986284

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

NCT00986284

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Suspended

Last Update Posted

Dec 22, 2015Estimated

Enrollment

102Actual

Phase

Phase 2

Conditions

Non Small Cell Lung Cancer

Interventions

gefitinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of patients and some progressed disease soon after surgery

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Sep 27, 2009

First Submission Date that Met QC Criteria

Sep 28, 2009

First Posted Date

Sep 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2015

Last Update Posted Date

Dec 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gefitinib, Neoadjuvant therapy	Experimental	Patients with EGFR mutation will be recruited and treated with gefitinib.	Drug: gefitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gefitinib	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.

Measure	Description	Time Frame
Response Rate		1 month

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Changli Wang, MD	Tianjin Medical University Cancer Institute and Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Cancer Institute & Hospital		Tianjin	Tianjin Municipality	300060	China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077156	Gefitinib

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided