Lung CancerPhase 2NCT01737216
Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
A Phase 2 study testing Zoledronic acid plus EP/TP and EP/TP in people with Lung Cancer, run by Hebei Tumor Hospital at 1 site in China.
Trial summary
Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Zoledronic acid plus EP/TP and EP/TP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Dec 2016
- Phase
- Phase 2
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Signed informed consent form
- Age ≥70 years
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically or cytologically confirmed lung cancer
- Did not receive bisphosphonate treatment
Who cannot join
- Appear relapse and metastasis
- receive other bisphosphonate treatment
- Active or uncontrolled infection
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.
- Conditions
- Lung Cancer
- Being tested
- Zoledronic acid plus EP/TP, EP/TP
- Keywords
- Aged, patients
- 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 acid plus EP/TPDrug
Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
EP/TPDrug
Also called First-line chemotherapy
Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid plus First-line chemotherapy | Experimental | Not described Receives: Drug: Zoledronic acid plus EP/TP |
| First-line chemotherapy | Active comparator | Not described Receives: Drug: EP/TP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Measured: 1 year
Secondary outcomes (3)
Overall survival(OS)
Measured: 3 years
Bone mineral density(BMD)
Measured: 1 year
Quality of life(QOL)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2016 (estimated)
- Study completionDec 2016 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Liu, Principal investigator, Hebei Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737216
- Sponsor's protocol ID
- HBTH201
- Other IDs
- Hebei Tumor Hospital
- Status last verified
- Nov 2012
- First submitted
- 27 Nov 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT01737216
- Acronym / sponsor ID
- HBTH201
- Conditions
- Lung Cancer
- Keywords
- Aged, patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Tumor HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Nov 2012 (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.
Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid plus First-line chemotherapy | Experimental | Drug: Zoledronic acid plus EP/TP |
| First-line chemotherapy | Active comparator | Drug: EP/TP |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form
- Age ≥70 years
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically or cytologically confirmed lung cancer
- Did not receive bisphosphonate treatment
Key exclusion criteria (4 listed)
- Appear relapse and metastasis
- receive other bisphosphonate treatment
- Active or uncontrolled infection
- Pregnant or lactating women
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 acid plus EP/TPDrug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression | Drug | Zoledronic acid plus First-line chemotherapy |
| EP/TPAlso: First-line chemotherapyDrug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles | Drug | First-line chemotherapy |
Primary outcome
Progression-free survival(PFS)
Time frame: 1 year
3 secondary outcomes
Overall survival(OS)
Time frame: 3 years
Bone mineral density(BMD)
Time frame: 1 year
Quality of life(QOL)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
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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.
Wei Liu principal investigator
Hebei Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic acid plus EP/TP and EP/TP in people with Lung Cancer, run by Hebei Tumor 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 5 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 31 Dec 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Progression-free survival(PFS) (time frame: 1 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 31 Dec 2012.