Bone MetastasisPhase 2NCT02784652
Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors
A Phase 2 study testing Zoledronic acid and Radiotherapy in people with Bone Metastasis and Gastrointestinal Cancer, run by Severance Hospital at 1 site in South Korea.
Trial summary
Bone metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bone Metastasis, Gastrointestinal Cancer
- What is being tested?
- Zoledronic acid and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to 28 Feb 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiologic detectable bone metastasis (spine or non-spine)
- Patients with clinical diagnosis of gastrointestinal cancer: esophagus, stomach, colorectum, anus, liver, pancreas, gallbladder, biliary tract, etc.
- Patients over 20 years of age of both genders
- ECOG: 0 ~ 2
- Pain: worst pain score on BPI ≥3
Who cannot join
- Undetectable bone metastasis on radiologic study
- Patients who have previous surgery history at same site
- Patients who are considered surgery first: pathologic fracture, neurological or radiological evidence of spinal cord compression, impending pathologic fracture
- Patients who have hypersensitivity for zoledronic acid or other bisphosphonate
- Patients who have treatment history with zoledronic acid or other bisphosphonate
- Abnormal renal function or history of kidney transplantation
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- Patients with metabolic bone disease
- Synchronous symptomatic brain metastasis
- Women who are pregnant, breast-feeding, or possible pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Efficacy of Radiotherapy in Combination With Zoledronic Acid on Pain Relief in Bone Metastasis Patients With Gastrointestinal Tumors
Bone metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis.
The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In previous retrospective reports, the combination of local RT and systemic bisphosphonate was more effective than RT alone.
Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in combination with zoledronic acid on pain relief and the safety of RT in bone metastasis patients with gastrointestinal tumors.
- Conditions
- Bone Metastasis, Gastrointestinal Cancer
- Being tested
- Zoledronic acid, Radiotherapy
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called Zolenic, Zometa
Zoledronic acid: every 4 weeks, 6 times, 4.0 mg iv
RadiotherapyRadiation
Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions,
| Study group | Role | What they receive |
|---|---|---|
| RT & Zoledronic acid | Experimental | Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions, Zoleronic acid: every 4 weeks, 6 times, 4.0 mg iv Receives: Drug: Zoledronic acid; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief rate
Measured: Change from baseline pain extent at 1,3,6 months
Secondary outcomes (2)
skeletal related events (fracture and spinal cord compression)
skeletal related events (SRE) (fracture, spinal cord compression due to metastasis requiring operation or radiotherapy. Occurence of pain is not regarded as SRE.) (SRE including fracture will be evaluated with plain X-ray at 1 month after completion of RT, and plain X-ray and MRI at 3 months after completion of RT.
all imaging studies will be reviwed by clinician and radiologist.)
Measured: at 18months after the IRB approval
Overall survival
Measured: at 18months after the IRB approval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2014
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsil Seong, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784652
- Sponsor's protocol ID
- 4-2014-0440
- Status last verified
- Mar 2017
- First submitted
- 1 May 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Efficacy of Radiotherapy in Combination With Zoledronic Acid on Pain Relief in Bone Metastasis Patients With Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT02784652
- Acronym / sponsor ID
- 4-2014-0440
- Conditions
- Bone Metastasis, Gastrointestinal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 27 May 2016 (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 metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis.
The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In previous retrospective reports, the combination of local RT and systemic bisphosphonate was more effective than RT alone.
Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in combination with zoledronic acid on pain relief and the safety of RT in bone metastasis patients with gastrointestinal tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT & Zoledronic acid | Experimental | Drug: Zoledronic acid, Radiation: RadiotherapyRadiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions, Zoleronic acid: every 4 weeks, 6 times, 4.0 mg iv |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with radiologic detectable bone metastasis (spine or non-spine)
- Patients with clinical diagnosis of gastrointestinal cancer: esophagus, stomach, colorectum, anus, liver, pancreas, gallbladder, biliary tract, etc.
- Patients over 20 years of age of both genders
- ECOG: 0 ~ 2
- Pain: worst pain score on BPI ≥3
Key exclusion criteria (9 listed)
- Undetectable bone metastasis on radiologic study
- Patients who have previous surgery history at same site
- Patients who are considered surgery first: pathologic fracture, neurological or radiological evidence of spinal cord compression, impending pathologic fracture
- Patients who have hypersensitivity for zoledronic acid or other bisphosphonate
- Patients who have treatment history with zoledronic acid or other bisphosphonate
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: Zolenic, ZometaZoledronic acid: every 4 weeks, 6 times, 4.0 mg iv | Drug | RT & Zoledronic acid |
| RadiotherapyRadiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions, | Radiation | RT & Zoledronic acid |
Primary outcome
Pain relief rate
Time frame: Change from baseline pain extent at 1,3,6 months
2 secondary outcomes
skeletal related events (fracture and spinal cord compression)
Time frame: at 18months after the IRB approval
Overall survival
Time frame: at 18months after the IRB approval
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 29 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Radiotherapy in people with Bone Metastasis and Gastrointestinal Cancer, run by Severance Hospital at 1 site in South Korea.
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 9 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 29 Mar 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 South Korea. 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?
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?
Pain relief rate (time frame: Change from baseline pain extent at 1,3,6 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 29 Mar 2017.