Metastatic CancerNCT00608855
Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases
A study testing questionnaire administration, cryosurgery and pain therapy in people with Metastatic Cancer and Pain, run by Mayo Clinic at 10 sites in United States.
Trial summary
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases. PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- questionnaire administration, cryosurgery and pain therapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2003to Feb 2013
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic solid tumor involving or abutting bone (index lesion)
- If the nature of the metastatic disease has been previously documented, index lesion to be treated does not require further documentation (i.e., biopsy)
- Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or analgesics) or patient is considered a poor candidate for conventional therapies
- Radiation oncology consult is required if the patient is considered clinically to be a candidate for conventional palliative radiotherapy
- Surgical oncology consult is required if the patient is considered clinically to be a candidate for conventional surgical treatment or is considered at risk for complications resulting from potential fracture
- Initial pain score ≥ 4 on a scale of 0-10 for the question "Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours" on the Cleeland Brief Pain Inventory
- Pain from ≤ 2 sites of metastatic disease
- No lesions with evidence for impending fracture involving a weight-bearing bone (> 50% loss of cortical bone at the site)
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 2 months
- Platelet count ≥ 75,000/mm³
- ANC > 1,500/mm³ (for patients who have recently been treated with chemotherapy)
- INR ≤ 1.2
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior radiotherapy
- More than 3 weeks since initiation of a new chemotherapy regimen, including bisphosphonates
- More than 7 days since prior antiplatelet medications or clopidogrel
- More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs
- No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena cava, or within 1 cm of bowel or bladder
- No prior radiofrequency ablation for pain palliation of the same lesion
- No concurrent regular or low molecular weight heparin or other anticoagulants
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Brown University School of Medicine
Providence, Rhode Island, 02912
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.
PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
Read the detailed description
OBJECTIVES:
- To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases.
- To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment.
- To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy.
- To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment.
Patients complete pain and quality of life questionnaires periodically.
After completion of study treatment, patients are followed periodically for 2 years.
- Being tested
- questionnaire administration, cryosurgery, pain therapy, quality-of-life assessment
- Keywords
- bone metastases, pain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Neoplasm Metastasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
cryosurgeryProcedure or surgery
pain therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
Secondary outcomes (3)
Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
Percentage of patients who are able to reduce analgesic medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startNov 2003
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew R. Callstrom, MD, PhD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608855
- Sponsor's protocol ID
- MC03C3
- Other IDs
- MAYO-MC03C3
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2008
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00608855
- Acronym / sponsor ID
- MC03C3
- Keywords
- bone metastases, pain, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2003
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Feb 2008 (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.
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.
PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
Detailed description
OBJECTIVES:
- To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases.
- To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment.
- To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy.
- To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment.
Patients complete pain and quality of life questionnaires periodically.
After completion of study treatment, patients are followed periodically for 2 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| questionnaire administration | Other | – |
| cryosurgery | Procedure or surgery | – |
| pain therapy | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
3 secondary outcomes
Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
Percentage of patients who are able to reduce analgesic medications
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 12 Jan 2017.
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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.
Matthew R. Callstrom, MD, PhD study chair
Mayo Clinic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, cryosurgery and pain therapy in people with Metastatic Cancer and Pain, run by Mayo Clinic at 10 sites 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?
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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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?
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8. 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 12 Jan 2017.