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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00986284
Other study ID # TMU-CIH-LCC-001
Secondary ID
Status Suspended
Phase Phase 2
First received September 27, 2009
Last updated December 21, 2015
Start date September 2009
Est. completion date November 2016

Study information

Verified date August 2012
Source Tianjin Medical University Cancer Institute and Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Suspended
Enrollment 102
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
China Tianjin Cancer Institute & Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response Rate 1 month No
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