The Evaluation of Lung Cancer Patient Treated With Epider... | NCT02755337

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

NCT02755337

Sponsor

Dr. Soetomo General Hospital

Status

Unknown status

Last Update Posted

Apr 28, 2016Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Non-Small-Cell Lung Cancer

Interventions

Not provided

Countries

Indonesia

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jul 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Apr 25, 2016

First Submission Date that Met QC Criteria

Apr 27, 2016

First Posted Date

Apr 28, 2016Estimated

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

Apr 27, 2016

Last Update Posted Date

Apr 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laksmi Wulandari, MD, PhD, FCCP, MD, PhD, Dr. Soetomo General HospitalPrincipal Investigator

Lead Sponsor

Dr. Soetomo General HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS (Progression Free Survival)	Progression Free Survival (PFS) as defined by RECIST 1.1 or attending physician's clinical judgement of clinical progression state	through study completion, in average of 1 year
Overall Survival (OS)	Overall Survival (OS) as defined by the date of death certificate given by the attending physician or by other government officials	through study completion, in average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

NSCLC patients (adenocarcinoma and non-adenocarcinoma histology) who harbor a positive EGFR mutation and receive Gefitinib (Iressa) as treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laksmi Wulandari, MD, PhD	Contact	+628123019591		laksmigts@yahoo.co.id
Anna Febriani, MD	Contact	+62818703492		annafebriani@yahoo.com

Overall Officials

Name	Affiliation	Role
Laksmi Wulandari, MD, PhD	Dr. Soetomo General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Soetomo General Hospital	Recruiting	Surabaya	East Java	60286	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D000230	Adenocarcinoma

Ancestor Terms

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

Browse Leaves

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Browse Branches

Not provided