Non-small Cell Lung CancerPhase 4BLESTNCT00765687
Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates
A Phase 4 study testing bisphosphates in people with Non-small Cell Lung Cancer and Bone Metastases, run by Sun Yat-sen University at 1 site in China.
Trial summary
A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer, Bone Metastases
- What is being tested?
- bisphosphates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to May 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18, either sex
- Histologically confirmed non-small cell cancer
- One bone metastasis at least confirmed by image(X ray,CT or others)
- Without receiving zoledronic acid
- Life expectancy > 6 M
- ECOG <= 2
- Signed ICF
Who cannot join
- Women who are pregnant or in lactation
- Patients with hyperostosis
- with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
- Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates
A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.
- Conditions
- Non-small Cell Lung Cancer, Bone Metastases
- Being tested
- bisphosphates
- 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.
bisphosphatesDrug
any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Not described Receives: Drug: bisphosphates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeleton-related event
Measured: 24 months
Secondary outcomes (1)
overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2012
- Study completionMay 2012
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.
- More trials run by Sun Yat-sen 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Zhang Li, Master, Principal investigator, Cancer Center of Sun Yat-Sen University (CCSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765687
- Sponsor's protocol ID
- CZOL446ECN07
- Acronym
- BLEST
- Status last verified
- Dec 2011
- First submitted
- 29 Sep 2008
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates
- ClinicalTrials.gov ID
- NCT00765687
- Acronym / sponsor ID
- BLEST / CZOL446ECN07
- Conditions
- Non-small Cell Lung Cancer, Bone Metastases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Oct 2008 (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.
A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | Drug: bisphosphates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18, either sex
- Histologically confirmed non-small cell cancer
- One bone metastasis at least confirmed by image(X ray,CT or others)
- Without receiving zoledronic acid
- Life expectancy > 6 M
Key exclusion criteria (5 listed)
- Women who are pregnant or in lactation
- Patients with hyperostosis
- with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
- Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
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 |
|---|---|---|
| bisphosphatesany bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily | Drug | Observation |
Primary outcome
Skeleton-related event
Time frame: 24 months
1 secondary outcome
overall survival
Time frame: 24 months
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 10 Dec 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.
Zhang Li, Master principal investigator
Cancer Center of Sun Yat-Sen University (CCSU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bisphosphates in people with Non-small Cell Lung Cancer and Bone Metastases, run by Sun Yat-sen University 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 7 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 10 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Skeleton-related event (time frame: 24 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 10 Dec 2013.