Kidney CancerPhase 3NCT00540969
Cryoablation or External-Beam Radiation Therapy in Treating Patients With Painful Bone Metastases
A Phase 3 study testing cryosurgery and radiation therapy in people with Kidney Cancer and Melanoma (Skin), run by Alliance for Clinical Trials in Oncology at 7 sites in United States.
Trial summary
RATIONALE: Cryoablation kills cancer cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether cryoablation is more effective than external-beam radiation therapy in treating painful bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Melanoma (Skin), Metastatic Cancer
- What is being tested?
- cryosurgery and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2008to Jan 2010
- Phase
- Phase 3
- 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
- Histologically or cytologically confirmed solid tumor metastasis with index lesion involving or abutting bone
- Index lesion with bone destruction is predominantly osteolytic in nature as assessed on CT imaging
- If the nature of the metastatic disease has been previously documented, the index lesion to be treated does not require further documentation (i.e., biopsy)
- One primary painful metastatic site
- Additional less painful metastatic sites may be present
- Worst pain in the last 24 hours must be ≥ 4 on a 0-10 numeric scale
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- Current analgesic therapies have failed OR the patient is experiencing intolerable side effects
- Tumor is appropriate for radiotherapy as determined by the participating radiation oncologist and accessible for cryoablation as determined by the participating radiologists upon review of ultrasound, CT scan, X-ray, or MRI examinations
- Have completed chemotherapy, hormonal therapy, or bisphosphonate therapy ≥ 4 weeks prior to registration OR have developed pain or have persistent pain while on a stable chemotherapy, hormonal therapy, or bisphosphonate therapy regimen for a period of ≥ 4 weeks
- See Disease Characteristics
- No concurrent medication known to interfere with platelet function or coagulation (e.g., aspirin, ibuprofen, clopidogrel, or warfarin) and such medications have been discontinued for an appropriate time period based on the drug half-life and known activity (e.g., aspirin for 7 days) for patients randomized to receive cryoablation only
- Low molecular weight heparin preparations must be discontinued 8 hours prior to cryoablation
- At least 2 weeks since prior cytotoxic chemotherapy (for patients randomized to receive cryoablation only)
Who cannot join
- Index lesion causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
- Index lesion involves the skull
- Treatment of other painful lesions in patients with skull lesions is not excluded
- Index lesion has evidence of a pathologic fracture or impending fracture in weight-bearing bones (e.g., vertebral body, periacetabular region, femur, or tibia) with > 50% loss of cortical bone
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
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- Life expectancy ≥ 2 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Has undergone prior cryoablation or radiotherapy of the index lesion
- Prior radiopharmaceutical therapy completed ≤ 4 weeks prior to registration
- Initiation of new chemotherapy ≤ 4 weeks prior to registration
- Concurrent surgery involving the treated lesion
- Anticipated treatment of the index lesion that would require ice-ball formation within 0.5 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or IVC, bowel, or bladder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
About this study
Official title: A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases
RATIONALE: Cryoablation kills cancer cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether cryoablation is more effective than external-beam radiation therapy in treating painful bone metastases.
PURPOSE: This randomized phase III clinical trial is studying cryoablation to see how well it works compared with external-beam radiation therapy in treating patients with painful bone metastases.
Read the detailed description
OBJECTIVES:
- To determine pain relief in cancer patients with painful metastatic disease involving bone following treatment with cryoablation as compared to radiotherapy (RT).
- To compare the impact on quality-of-life following cryoablation or RT in patients with painful metastatic disease as measured using the validated Brief Pain Inventory (BPI) and Short Form (SF)-8.
- To determine change in analgesic use following therapy.
- To determine the frequency and severity of complications following treatment of painful metastases involving bone with either cryoablation or RT.
OUTLINE: This is a multicenter study. Patients are stratified according to size of the indexing lesion (≤ 5 cm vs > 5 cm), location of the target lesion (pelvis vs extremity vs vertebral body vs other), primary cancer type (melanoma or renal cell carcinoma vs other), and severity of pain (i.e., worst pain score in the last 24-hour period) (4-6 vs 7-10). Patients are randomized to 1 of 2 treatment arms.
- Arm I (percutaneous cryoablation): Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
- Arm II (external-beam radiotherapy): Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
Patients are contacted via phone on days 1 and 4 post treatment, weekly in weeks 1-4, every 2 weeks in weeks 6-24, and then every four weeks in weeks 28-36. Patients undergo pain and pain interference with daily life assessment at baseline and at these time points. Patients who elect to have repeated treatment (either radiotherapy or cryoablation) within the first 6 weeks after the initial treatment are removed from the study. Patients who fail to achieve a 2-point reduction in worst or average pain (in a 24-hour period) during weeks 6-20 after initial treatment and patients who report a return of pain (i.e., pain ≥ the worst pain in a 24-hour period reported at baseline) for 2 consecutive time points are offered the alternative treatment (radiotherapy or cryoablation, whichever the patient was not randomized to receive at initial treatment)*.
NOTE: *Patients who refuse to receive the alternative treatment are taken off study.
- Conditions
- Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- cryosurgery, radiation therapy
- Keywords
- bone metastases, pain, unspecified adult solid tumor, protocol specific, stage IV melanoma, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Melanoma, Neoplasm Metastasis, Pain, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryosurgeryProcedure or surgery
Patients undergo cryosurgery using guidance from CT scan or ultrasound
radiation therapyRadiation
Patients undergo radiotherapy for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Arm I (percutaneous cryoablation) | Experimental | Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively. Receives: Procedure: cryosurgery |
| Arm II (external-beam radiotherapy) | Active comparator | Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week. Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale
Measured: at week 6
Secondary outcomes (2)
Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI
Measured: at week 6
Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8
Measured: at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Low accrual
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 Kidney CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- 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
- NCT00540969
- Sponsor's protocol ID
- NCCTG-N06C6
- Other IDs
- NCI-2009-00690, CDR0000570788
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2007
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases
- ClinicalTrials.gov ID
- NCT00540969
- Acronym / sponsor ID
- NCCTG-N06C6
- Conditions
- Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- bone metastases, pain, unspecified adult solid tumor, protocol specific, stage IV melanoma, stage IV renal cell cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2008 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Posted 1 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Cryoablation kills cancer cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether cryoablation is more effective than external-beam radiation therapy in treating painful bone metastases.
PURPOSE: This randomized phase III clinical trial is studying cryoablation to see how well it works compared with external-beam radiation therapy in treating patients with painful bone metastases.
Detailed description
OBJECTIVES:
- To determine pain relief in cancer patients with painful metastatic disease involving bone following treatment with cryoablation as compared to radiotherapy (RT).
- To compare the impact on quality-of-life following cryoablation or RT in patients with painful metastatic disease as measured using the validated Brief Pain Inventory (BPI) and Short Form (SF)-8.
- To determine change in analgesic use following therapy.
- To determine the frequency and severity of complications following treatment of painful metastases involving bone with either cryoablation or RT.
OUTLINE: This is a multicenter study. Patients are stratified according to size of the indexing lesion (≤ 5 cm vs > 5 cm), location of the target lesion (pelvis vs extremity vs vertebral body vs other), primary cancer type (melanoma or renal cell carcinoma vs other), and severity of pain (i.e., worst pain score in the last 24-hour period) (4-6 vs 7-10). Patients are randomized to 1 of 2 treatment arms.
- Arm I (percutaneous cryoablation): Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
- Arm II (external-beam radiotherapy): Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
Patients are contacted via phone on days 1 and 4 post treatment, weekly in weeks 1-4, every 2 weeks in weeks 6-24, and then every four weeks in weeks 28-36. Patients undergo pain and pain interference with daily life assessment at baseline and at these time points. Patients who elect to have repeated treatment (either radiotherapy or cryoablation) within the first 6 weeks after the initial treatment are removed from the study. Patients who fail to achieve a 2-point reduction in worst or average pain (in a 24-hour period) during weeks 6-20 after initial treatment and patients who report a return of pain (i.e., pain ≥ the worst pain in a 24-hour period reported at baseline) for 2 consecutive time points are offered the alternative treatment (radiotherapy or cryoablation, whichever the patient was not randomized to receive at initial treatment)*.
NOTE: *Patients who refuse to receive the alternative treatment are taken off study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (percutaneous cryoablation) | Experimental | Procedure: cryosurgeryCryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively. |
| Arm II (external-beam radiotherapy) | Active comparator | Radiation: radiation therapyPatients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed solid tumor metastasis with index lesion involving or abutting bone
- One primary painful metastatic site
- Worst pain in the last 24 hours must be ≥ 4 on a 0-10 numeric scale
- Current analgesic therapies have failed OR the patient is experiencing intolerable side effects
- Tumor is appropriate for radiotherapy as determined by the participating radiation oncologist and accessible for cryoablation as determined by the participating radiologists upon review of ultrasound, CT scan, X-ray, or MRI examinations
Key exclusion criteria (16 listed)
- Index lesion causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
- Index lesion involves the skull
- Index lesion has evidence of a pathologic fracture or impending fracture in weight-bearing bones (e.g., vertebral body, periacetabular region, femur, or tibia) with > 50% loss of cortical bone
- ECOG performance status 0-2
- Life expectancy ≥ 2 months
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 |
|---|---|---|
| cryosurgeryPatients undergo cryosurgery using guidance from CT scan or ultrasound | Procedure or surgery | Arm I (percutaneous cryoablation) |
| radiation therapyPatients undergo radiotherapy for 1 week | Radiation | Arm II (external-beam radiotherapy) |
Primary outcome
Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale
Time frame: at week 6
2 secondary outcomes
Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI
Time frame: at week 6
Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8
Time frame: at week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
Matthew R. Callstrom, MD, PhD study chair
Mayo Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cryosurgery and radiation therapy in people with Kidney Cancer and Melanoma (Skin), run by Alliance for Clinical Trials in Oncology at 7 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?
The sponsor lists 13 inclusion and 16 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 21 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 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 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?
Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale (time frame: at week 6). 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 21 Nov 2018.