Overal Survival, Non-small Cell Lung CancerNCT03157310
Bone Metastasis on the Survival of Gefitinib Effective Patients
A study testing Gefitinib in people with Overal Survival, Non-small Cell Lung Cancer, run by Qilu Hospital of Shandong University.
Trial summary
Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Overal Survival, Non-small Cell Lung Cancer
- What is being tested?
- Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2009to 12 Jul 2015
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological and (or) cytological diagnosed NSCLC patients.
- patient was effective in Gefitinib treatment more than 6 months.
- whether patient received chemotherapy and other treatment is not restricted.
- whether patient was detected for EGFR gene mutation was not restricted.
Who cannot join
- patient with small cell lung cancer.
- patient without cytology or histopathology diagnosis results.
- patient with bone metastases cannot rule out other reasons such as inflammation or trauma.
- patient with poor treatment compliance.
- patient with incomplete data.
About this study
Official title: Bone Metastasis on the Survival of Gefitinib Effective Patients With Non-small Cell Lung Cancer
Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.
Read the detailed description
The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.
- Being tested
- Gefitinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called Iressa
Daily oral administration of 250 mg Gefitinib
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib | Experimental | Gefitinib is an selective small molecule epidermal growth factor receptors (EGFRs) tyrosine kinase inhibitors (EGFR-TKI) for non-small cell lung cancer. Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overal survival of patients
The 5-year survival of NSCLC patients with or without bone metastasis
Measured: 5 years
Secondary outcomes (1)
Survival of patients with both bone metastasis and brain metastasis
Survival of patients with both bone metastasis and brain metastasis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 May 2009
- Primary completion1 May 2013
- Study completion12 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overal Survival, Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hai-Chun Liu, Dr., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157310
- Sponsor's protocol ID
- 2017-QLH-11
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients' data were not allowed to been using outside this research.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Metastasis on the Survival of Gefitinib Effective Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03157310
- Acronym / sponsor ID
- 2017-QLH-11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 May 2009 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 12 Jul 2015 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.
Detailed description
The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefitinib | Experimental | Drug: GefitinibGefitinib is an selective small molecule epidermal growth factor receptors (EGFRs) tyrosine kinase inhibitors (EGFR-TKI) for non-small cell lung cancer. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histological and (or) cytological diagnosed NSCLC patients.
- patient was effective in Gefitinib treatment more than 6 months.
- whether patient received chemotherapy and other treatment is not restricted.
- whether patient was detected for EGFR gene mutation was not restricted.
Key exclusion criteria (5 listed)
- patient with small cell lung cancer.
- patient without cytology or histopathology diagnosis results.
- patient with bone metastases cannot rule out other reasons such as inflammation or trauma.
- patient with poor treatment compliance.
- patient with incomplete data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefitinibAlso: IressaDaily oral administration of 250 mg Gefitinib | Drug | Gefitinib |
Primary outcome
Overal survival of patients
Time frame: 5 years
The 5-year survival of NSCLC patients with or without bone metastasis
1 secondary outcome
Survival of patients with both bone metastasis and brain metastasis
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: No. The patients' data were not allowed to been using outside this research.
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.
Hai-Chun Liu, Dr. principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A study testing Gefitinib in people with Overal Survival, Non-small Cell Lung Cancer, run by Qilu Hospital of Shandong University.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overal survival of patients (time frame: 5 years). 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 17 May 2017.