The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

NCT ID: NCT02755337

Last Updated: 2016-04-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib.

Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small-Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* NSCLC based on histopathologic examination
* Adenocarcinoma and/or nonadenocarcinoma based on histology examination
* Clinical stadium stage IIIB and IV
* Age 16-70 years old
* Received gefitinib as therapy
* At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015

Exclusion Criteria

* Missing data of any variables of the treatment outcomes in the medical record
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Soetomo General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laksmi Wulandari, MD, PhD, FCCP

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laksmi Wulandari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dr. Soetomo General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Soetomo General Hospital

Surabaya, East Java, Indonesia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laksmi Wulandari, MD, PhD

Role: CONTACT

+628123019591

Anna Febriani, MD

Role: CONTACT

+62818703492

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laksmi Wulandari, MD. PhD

Role: primary

+628123019591

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Dr. Soetomo General Hospital

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.