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Cryoablation or External-Beam Radiation Therapy in Treating Patients With Painful Bone Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00540969
Recruitment Status : Terminated (Low accrual)
First Posted : October 8, 2007
Results First Posted : February 1, 2017
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 8, 2007
Results First Submitted Date  ICMJE December 7, 2016
Results First Posted Date  ICMJE February 1, 2017
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE February 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
  • Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI
  • 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
  • Average difference in pre- and post-treatment worst pain in 24 hours, average pain, pain relief, and pain interference scores at weeks 12, 24, and 36 as measured with the BPI
  • Average difference in pre- and post-treatment physical (PCS-8) and mental (MCS-8) quality of life at weeks 12, 24, and 36 as measured by the 2 subscales of the SF-8
  • Comparison of the proportion of treated tumors with at least a two-point decrease in worst pain score at weeks 6, 12, 24, and 36 after cryoablation or radiotherapy (RT)
  • Comparison of the proportion of treated tumors with at least a two-point decrease in average pain score at weeks 6, 12, 24, and 36 after cryoablation or RT
  • Comparison of change in analgesic use at weeks 6, 12, 24, and 36 after cryoablation or RT
  • Comparison of time to maximal pain relief after cryoablation or RT
  • Comparison of time to recurrence of worst pain at or above baseline worst pain score in the 36-week follow-up period as measured on a numeric 0 to 10 scale
  • Incidence of treatment-related adverse events for cryoablation and RT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryoablation or External-Beam Radiation Therapy in Treating Patients With Painful Bone Metastases
Official Title  ICMJE A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Cancer
  • Melanoma (Skin)
  • Metastatic Cancer
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Procedure: cryosurgery
    Patients undergo cryosurgery using guidance from CT scan or ultrasound
  • Radiation: radiation therapy
    Patients undergo radiotherapy for 1 week
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Procedure: cryosurgery
  • Active Comparator: 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.
    Intervention: Radiation: radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 8, 2015)
3
Original Enrollment  ICMJE
 (submitted: October 5, 2007)
140
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • 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
  • 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

Exclusion criteria:

  • 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
  • Life expectancy ≥ 2 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • 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)

Exclusion criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00540969
Other Study ID Numbers  ICMJE NCCTG-N06C6
NCI-2009-00690 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000570788 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Matthew R. Callstrom, MD, PhD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP