Bone MetastasesNCT01767935
Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
A study testing cryosurgery, radiation therapy and quality-of-life assessment in people with Bone Metastases and Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Pain
- What is being tested?
- cryosurgery, radiation therapy and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologically (histologically or cytologically) confirmed metastatic disease with a new tumor involving or abutting bone that has the clinical and imaging features of metastatic disease
- If the nature of the metastatic disease has been previously documented, index tumor to be treated does not require further documentation (i.e., biopsy)
- Current analgesic therapies have failed (worst pain of 4 or above as measured by Brief Pain Inventory [BPI], despite analgesic therapy) OR the subject is experiencing intolerable side effects that preclude analgesic use (resulting in pain of 4 or above, as measured by BPI)
- Pain must be from one or two painful metastatic sites in the bone (additional less painful metastatic sites may be present)
- Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, magnetic resonance imaging (MRI), or ultrasound (US) imaging
- Metastatic tumors must be amenable to cryoablation with CT or MRI
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- If the index tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
- Patients must have stable use of hormonal therapy for two weeks prior to study registration and two weeks prior to cryoablation procedure)
- Stable use of pain medications (no changes within two weeks of cryoablation procedure)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >= 2 months
- Platelets > 50,000/mm^3
- International normalized ratio (INR) >= 1.5
- Patients may not have any debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- Patients who are taking antiplatelet or anticoagulation medication (e.g., aspirin, ibuprofen, low molecular weight heparin [LMWH] preparations) must be able to discontinue such treatment prior to the cryoablation procedure for an appropriate amount of time; at least 5 days should be allowed after discontinuation of aspirin, Coumadin, clopidogrel, and dipyridamole; at least 12 hours should be allowed after discontinuation of LMWH preparations
- Patients must be clinically suitable for cryoablation therapy
- Patients must be clinically suitable for radiation therapy
- Patients must be able to understand and willing to sign a written informed consent document
Who cannot join
- Patients with a diagnosis of leukemia, lymphoma, or myeloma
- Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
- Patients who have undergone prior ablation treatment or radiation therapy of the index tumor
- Patients who have received chemotherapy within 14 days prior to and 14 days after cryoablation procedure
- Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine compression/effacement
- Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava (IVC), bowel, or bladder
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- Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor
- Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
- Patients with uncontrolled coagulopathy or bleeding disorders
- Patients who are pregnant, nursing, or who wish to become pregnant during the study
- Patients with active, uncontrolled infection
- Patients with serious medical illnesses, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within six months prior to study entry
- Patients who are concurrently participating in any other experimental studies that could affect the primary endpoint of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy
This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases.
OUTLINE:
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.
- Conditions
- Bone Metastases, Pain
- Being tested
- cryosurgery, radiation therapy, quality-of-life assessment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryosurgeryProcedure or surgery
Also called cryoablation, cryosurgical ablation
Undergo cryosurgery
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cryosurgery and radiation therapy) | Experimental | Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Procedure: cryosurgery; Radiation: radiation therapy; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.
Measured: 24 hours
Secondary outcomes (4)
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.
Measured: Baseline to 24 weeks
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: Up to 24 weeks
Pain After Cryosurgery, as Measured by the BPI
Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome
Measured: Up to 24 weeks
Number of Participants Who Survived
Count of participants that survived.
Measured: Up to 24 weeks post-cryosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Slow Accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Endocare, Inc.
- Responsible party
- Sponsor
- Investigators
- David Childs, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767935
- Sponsor's protocol ID
- IRB00020528
- Other IDs
- NCI-2012-02087, P30CA012197, CCCWFU 97212
- Status last verified
- Oct 2018
- First submitted
- 11 Jan 2013
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy
- ClinicalTrials.gov ID
- NCT01767935
- Acronym / sponsor ID
- IRB00020528
- Conditions
- Bone Metastases, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accruals
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Endocare, Inc.
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells
Detailed description
PRIMARY OBJECTIVES:
- To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases.
OUTLINE:
Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cryosurgery and radiation therapy) | Experimental | Procedure: cryosurgery, Radiation: radiation therapy, Procedure: quality-of-life assessmentPatients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Pathologically (histologically or cytologically) confirmed metastatic disease with a new tumor involving or abutting bone that has the clinical and imaging features of metastatic disease
- Current analgesic therapies have failed (worst pain of 4 or above as measured by Brief Pain Inventory [BPI], despite analgesic therapy) OR the subject is experiencing intolerable side effects that preclude analgesic use (resulting in pain of 4 or above, as measured by BPI)
- Pain must be from one or two painful metastatic sites in the bone (additional less painful metastatic sites may be present)
- If the index tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
- Patients must have stable use of hormonal therapy for two weeks prior to study registration and two weeks prior to cryoablation procedure)
Key exclusion criteria (13 listed)
- Patients with a diagnosis of leukemia, lymphoma, or myeloma
- Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
- Patients who have undergone prior ablation treatment or radiation therapy of the index tumor
- Patients who have received chemotherapy within 14 days prior to and 14 days after cryoablation procedure
- Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine compression/effacement
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 |
|---|---|---|
| cryosurgeryAlso: cryoablation, cryosurgical ablationUndergo cryosurgery | Procedure or surgery | Treatment (cryosurgery and radiation therapy) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Treatment (cryosurgery and radiation therapy) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Treatment (cryosurgery and radiation therapy) |
Primary outcome
Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
Time frame: 24 hours
Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.
4 secondary outcomes
Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
Time frame: Baseline to 24 weeks
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 24 weeks
Pain After Cryosurgery, as Measured by the BPI
Time frame: Up to 24 weeks
Number of Participants Who Survived
Time frame: Up to 24 weeks post-cryosurgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Childs principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryosurgery, radiation therapy and quality-of-life assessment in people with Bone Metastases and Pain, run by Wake Forest University Health Sciences at 1 site in United States.
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 18 inclusion and 13 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 14 Nov 2018. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Level at 24 Hours Before Cryosurgery, as Measured by the BPI (time frame: 24 hours). 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 14 Nov 2018.