Non Small Cell Lung CancerNCT01891708
VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer and Brain Metastasis, run by Li Liu at 1 site in China.
Trial summary
a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Brain Metastasis
- What is being tested?
- bevacizumab, standard chemotherapy and radiation
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2018
- How long will I take part?
- 2 Months
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced non small cell lung cancer patients with brain metastatic disease
Who may be able to join
- non squamous cell non small cell lung cancer
- with measurable disease
- ECOG 0-1
Who cannot join
- patients received surgery in recent 4 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430071
Li Liu, MD, 027-85872015, liulixiehe@163.com
About this study
- VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer
Read the detailed description
- non small cell lung cancer (non squamous carcinoma)
- ECOG 0-1
- from 18-75 years old
- Conditions
- Non Small Cell Lung Cancer, Brain Metastasis
- Being tested
- bevacizumab, standard chemotherapy and radiation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab, standard chemotherapy and radiationOther
Also called Drug:bevacizumab,also Avastine, Drug:standard chemotherapy recommended by clinical guidlines, Radiation
the dose and application model of the three intervention are not specified by the sponsor who just observe the efficacy of the combination application of the three in non small cell lung cancer patients with brain metastasis once enrolled.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: 6 months
Secondary outcomes (1)
OS
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2018 (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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Li Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Liu, Huazhong University of Science and Technology
- Investigators
- Li Liu, MD, Principal investigator, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891708
- Sponsor's protocol ID
- XHZL02
- Status last verified
- Jul 2013
- First submitted
- 19 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01891708
- Acronym / sponsor ID
- XHZL02
- Conditions
- Non Small Cell Lung Cancer, Brain Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Li LiuUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Jul 2013 (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.
- VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer
Detailed description
- non small cell lung cancer (non squamous carcinoma)
- ECOG 0-1
- from 18-75 years old
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced non small cell lung cancer patients with brain metastatic disease
Key inclusion criteria (3 listed)
- non squamous cell non small cell lung cancer
- with measurable disease
- ECOG 0-1
Key exclusion criteria (1 listed)
- patients received surgery in recent 4 weeks
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 |
|---|---|---|
| bevacizumab, standard chemotherapy and radiationAlso: Drug:bevacizumab,also Avastine, Drug:standard chemotherapy recommended by clinical guidlines, Radiationthe dose and application model of the three intervention are not specified by the sponsor who just observe the efficacy of the combination application of the three in non small cell lung cancer patients with brain metastasis once enrolled. | Other | – |
Primary outcome
PFS
Time frame: 6 months
1 secondary outcome
OS
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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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.
Li Liu, MD principal investigator
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 and Brain Metastasis, run by Li Liu at 1 site in China.
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 3 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 3 Jul 2013. 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 China. 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 Li Liu, MD (027-85872015, liulixiehe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 months). 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 3 Jul 2013.