Non-Small-Cell Lung CancerEVALUATENCT02755337
The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase
An observational study of Non-Small-Cell Lung Cancer, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NSCLC patients (adenocarcinoma and non-adenocarcinoma histology) who harbor a positive EGFR mutation and receive Gefitinib (Iressa) as treatment.
Who may be able to join
- 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
Who cannot join
- Missing data of any variables of the treatment outcomes in the medical record
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Soetomo General Hospital
Surabaya, East Java, 60286
Laksmi Wulandari, MD. PhD, +628123019591, laksmigts@yahoo.co.id
Laksmi Wulandari, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- adenocarcinoma, non-adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression Free Survival)
Progression Free Survival (PFS) as defined by RECIST 1.1 or attending physician's clinical judgement of clinical progression state
Measured: 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
Measured: through study completion, in average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Laksmi Wulandari, MD, PhD, FCCP, Dr. Soetomo General Hospital
- Investigators
- Laksmi Wulandari, MD, PhD, Principal investigator, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755337
- Sponsor's protocol ID
- Dr. Soetomo General Hospital
- Acronym
- EVALUATE
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase
- ClinicalTrials.gov ID
- NCT02755337
- Acronym / sponsor ID
- EVALUATE / Dr. Soetomo General Hospital
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- adenocarcinoma, non-adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NSCLC patients (adenocarcinoma and non-adenocarcinoma histology) who harbor a positive EGFR mutation and receive Gefitinib (Iressa) as treatment.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Missing data of any variables of the treatment outcomes in the medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS (Progression Free Survival)
Time frame: through study completion, in average of 1 year
Progression Free Survival (PFS) as defined by RECIST 1.1 or attending physician's clinical judgement of clinical progression state
Overall Survival (OS)
Time frame: through study completion, in average of 1 year
Overall Survival (OS) as defined by the date of death certificate given by the attending physician or by other government officials
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laksmi Wulandari, MD, PhD principal investigator
Dr. Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small-Cell Lung Cancer, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laksmi Wulandari, MD, PhD (+628123019591, laksmigts@yahoo.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (Progression Free Survival) (time frame: through study completion, in average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.