Is Targeted Therapy Increasing Survival Inoperable Nonsmall Cell Lung Cancer With Spinal Metastasis ?NCT02740894
Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?
An observational study of Is Targeted Therapy Increasing Survival Inoperable Nonsmall Cell Lung Cancer With Spinal Metastasis ?, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
Not significantly increased survival in T/T Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Is Targeted Therapy Increasing Survival Inoperable Nonsmall Cell Lung Cancer With Spinal Metastasis ?
- What is being tested?
- Gefitinib
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NSCLC with spinal metastasis
Who may be able to join
- NSCLC with spinal metastasis
Who cannot join
- brain metastasis and expected survival < 3 months
About this study
Official title: Can Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis of the Thoracic and Lumbar Spine?- A Retrospective Comparison With Platinum-based Chemotherapy
Not significantly increased survival in T/T
- Being tested
- Gefitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called Targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| targeted therapy | according to national healthy policy, targeted therapy is the optional therapy Receives: Drug: Gefitinib | |
| traditional chemotherapy | according to national healthy policy, chemotherapy is the first line treatment. Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and neurologic outcome of 60 participants receiving targeted therapy for nonsmall cell lung cancer with spinal metastaasis. Neurological outcome by Frankel grading and ambulation status.
Measured: postoperation to mortality, up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Is Targeted Therapy Increasing Survival Inoperable Nonsmall Cell Lung Cancer With Spinal Metastasis ?Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740894
- Sponsor's protocol ID
- 2016-02-006CC
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis of the Thoracic and Lumbar Spine?- A Retrospective Comparison With Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT02740894
- Acronym / sponsor ID
- 2016-02-006CC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 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.
Not significantly increased survival in T/T
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| targeted therapy | – | Drug: Gefitinibaccording to national healthy policy, targeted therapy is the optional therapy |
| traditional chemotherapy | – | Drug: Gefitinibaccording to national healthy policy, chemotherapy is the first line treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NSCLC with spinal metastasis
Key inclusion criteria (1 listed)
- NSCLC with spinal metastasis
Key exclusion criteria (1 listed)
- brain metastasis and expected survival < 3 months
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: Targeted therapy | Drug | targeted therapy, traditional chemotherapy |
Primary outcome
Survival and neurologic outcome of 60 participants receiving targeted therapy for nonsmall cell lung cancer with spinal metastaasis. Neurological outcome by Frankel grading and ambulation status.
Time frame: postoperation to mortality, up to 2 year
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 15 Apr 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Is Targeted Therapy Increasing Survival Inoperable Nonsmall Cell Lung Cancer With Spinal Metastasis ?, run by Taipei Veterans General Hospital, Taiwan.
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 1 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: finished, as of the sponsor's last update on 15 Apr 2016. 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?
Survival and neurologic outcome of 60 participants receiving targeted therapy for nonsmall cell lung cancer with spinal metastaasis. Neurological outcome by Frankel grading and ambulation status. (time frame: postoperation to mortality, up to 2 year). 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 15 Apr 2016.