Lung CancerPhase 4NCT00492843
Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis
A Phase 4 study testing Ibandronate (Bondronat) in people with Lung Cancer, run by Chinese Society of Lung Cancer at 8 sites in China.
Trial summary
The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ibandronate (Bondronat)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesChina
- Study dates
- Jul 2007to Jul 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥ 18 years
- Histological or cytological evidence of lung cancer
- Presence of bone metastases documented on bone X-ray, bone ECT, CT scan or MRI scan
- Mean pain score ≥ 4 during 3-day baseline period on the WORSE pain scale of the VAS
- Patients must be on a stable dose of analgesics over the 3-day baseline period (maximum 15% variation is allowed)
- ECOG Performance status of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease)
- Adequate renal function: creatinine clearance ≥ 50 ml/min (cockroft formula) and serum creatinine ≤ 2.0mg/dl (168 µmol/L); ALT or AST within 2 times the upper limit of the normal range
Who cannot join
- Patients with an uncontrolled infection
- Hypocalcemia
- Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate
- Patients with known hypersensitivity to any of the components of ibandronic acid
- Patients who are pregnant or lactating
- Radiotherapy to bone within the 28 days prior inclusion or during the trial duration
- Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Cancer Hospital
Beijing
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Sun Yat-sen University Cancer Center
Guangzhou
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
The Tumor Hospital of Harbin Medical University
Harbin
Shanghai Chest Hospital
Shanghai
Shanghai Pulmonary Hospital
Shanghai
General Hospital of Tianjin Medical University
Tianjin
About this study
Official title: A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain
The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.
Read the detailed description
Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.
- Conditions
- Lung Cancer
- Being tested
- Ibandronate (Bondronat)
- Keywords
- Ibandronate, Lung cancer, bone metastasis
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibandronate (Bondronat)Drug
Also called no other names
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Intravenous infusion of either 6mg Bondronat on three consecutive days Receives: Drug: Ibandronate (Bondronat) |
| B | Active comparator | Intravenous infusion of 6mg Bondronat on one day Receives: Drug: Ibandronate (Bondronat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
Measured: 1 month
Secondary outcomes (1)
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJul 2008
Why it stopped: It is too difficult to recruit suitable patients.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Society of Lung Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Long Wu, Chinese Society of Lung Cancer
- Investigators
- Yilong Wu, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492843
- Sponsor's protocol ID
- CSLC0701
- Status last verified
- Feb 2016
- First submitted
- 25 Jun 2007
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT00492843
- Acronym / sponsor ID
- CSLC0701
- Conditions
- Lung Cancer
- Keywords
- Ibandronate, Lung cancer, bone metastasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is too difficult to recruit suitable patients.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese Society of Lung CancerUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jun 2007 (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.
The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.
Detailed description
Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ibandronate (Bondronat)Intravenous infusion of either 6mg Bondronat on three consecutive days |
| B | Active comparator | Drug: Ibandronate (Bondronat)Intravenous infusion of 6mg Bondronat on one day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Age ≥ 18 years
- Histological or cytological evidence of lung cancer
- Presence of bone metastases documented on bone X-ray, bone ECT, CT scan or MRI scan
- Mean pain score ≥ 4 during 3-day baseline period on the WORSE pain scale of the VAS
Key exclusion criteria (7 listed)
- Patients with an uncontrolled infection
- Hypocalcemia
- Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate
- Patients with known hypersensitivity to any of the components of ibandronic acid
- Patients who are pregnant or lactating
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 |
|---|---|---|
| Ibandronate (Bondronat)Also: no other namesIntravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. | Drug | A, B |
Primary outcome
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
Time frame: 1 month
1 secondary outcome
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters
Time frame: 1 month
Results and safety
The study was stopped early (reason given: It is too difficult to recruit suitable patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Related InfoLink provided by the sponsor.
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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.
Yilong Wu, MD principal investigator
Guangdong Provincial People's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibandronate (Bondronat) in people with Lung Cancer, run by Chinese Society of Lung Cancer at 8 sites 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was stopped early (reason given: It is too difficult to recruit suitable patients.). 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?
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption) (time frame: 1 month). 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 17 Feb 2016.