Lung CancerPhase 3NCT02622607
Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer
A Phase 3 study testing Zoledronic acid in people with Lung Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Mar 2018
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years of age, male or female
- histologically or cytologically confirmed stage IIIB or IV lung cancer at diagnosis
- no evidence of bone metastatic lesions was radiographically confirmed by bone scintigraphy
- life expectancy of ≥6 months
- adequate renal, hematologic, and hepatic
- Eastern Cooperative Oncology Group(ECOG) performance status≤2
- All patients provided written informed consent
Who cannot join
- Treatment with other bisphosphonates
- Presence of brain metastases
- Be allergic to ZOL
- attending other unlisted drug clinical trials,currently.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology，Tangdu Hospital，Fourth Millitary Medical University
Xi'an, Shaanxi, 710000
He-Long Zhang, M.D., 13519128910, zhanghelong@medmail.com.cn
Mi Jiao, M.M., 18392467550, mimi10903@126.com
About this study
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of skeletal-related events(SREs）from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid（ZOL) in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .
Read the detailed description
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. which can lead to pain, decreased mobility and skeletal complications .Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of SREs from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .
- Conditions
- Lung Cancer
- Being tested
- Zoledronic acid
- Keywords
- ZOL, Prevention, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called Zometa
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride)
| Study group | Role | What they receive |
|---|---|---|
| ZOL | Experimental | Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 months for 12 months. Receives: Drug: Zoledronic acid |
| Control | No intervention | No investigational treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Bone Metastases at 12 Months
Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
Measured: Months 12
Secondary outcomes (2)
Progression-Free Survival
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Measured: Up to 24 months
Percentage of Participants With Overall Survival
Measured: Months 6, 12, 18, and 24 ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He-Long Zhang, M.D., Study chair, Department of Oncology，Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622607
- Sponsor's protocol ID
- ZOL
- Status last verified
- Jul 2017
- First submitted
- 30 Nov 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer
- ClinicalTrials.gov ID
- NCT02622607
- Acronym / sponsor ID
- ZOL
- Conditions
- Lung Cancer
- Keywords
- ZOL, Prevention, lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 4 Dec 2015 (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.
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of skeletal-related events(SREs）from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid（ZOL) in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .
Detailed description
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. which can lead to pain, decreased mobility and skeletal complications .Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of SREs from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZOL | Experimental | Drug: Zoledronic acidZoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 months for 12 months. |
| Control | No intervention | –No investigational treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 70 years of age, male or female
- histologically or cytologically confirmed stage IIIB or IV lung cancer at diagnosis
- no evidence of bone metastatic lesions was radiographically confirmed by bone scintigraphy
- life expectancy of ≥6 months
- adequate renal, hematologic, and hepatic
Key exclusion criteria (4 listed)
- Treatment with other bisphosphonates
- Presence of brain metastases
- Be allergic to ZOL
- attending other unlisted drug clinical trials,currently.
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 |
|---|---|---|
| Zoledronic acidAlso: ZometaZoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride) | Drug | ZOL |
Primary outcome
Percentage of Participants With Bone Metastases at 12 Months
Time frame: Months 12
Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
2 secondary outcomes
Progression-Free Survival
Time frame: Up to 24 months
Percentage of Participants With Overall Survival
Time frame: Months 6, 12, 18, and 24 ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
He-Long Zhang, M.D. study chair
Department of Oncology，Tangdu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic acid in people with Lung Cancer, run by Tang-Du Hospital 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 4 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 21 Jul 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 He-Long Zhang, M.D. (13519128910, zhanghelong@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Bone Metastases at 12 Months (time frame: Months 12). 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 21 Jul 2017.