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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00540969
First received: October 5, 2007
Last updated: January 28, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: cryosurgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average difference in pre- and post-treatment average pain, pain relief, and pain interference scores at week 6 as measured with the BPI [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Comparison of change in analgesic use at weeks 6, 12, 24, and 36 after cryoablation or RT [ Designated as safety issue: No ]
  • Comparison of time to maximal pain relief after cryoablation or RT [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Incidence of treatment-related adverse events for cryoablation and RT [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: February 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: cryosurgery
Patients undergo cryosurgery using guidance from CT scan or ultrasound
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.
Radiation: radiation therapy
Patients undergo radiotherapy for 1 week

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540969

Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Matthew R. Callstrom, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Charles L. Loprinzi, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00540969     History of Changes
Other Study ID Numbers: CDR0000570788, NCCTG-N06C6
Study First Received: October 5, 2007
Last Updated: January 28, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
bone metastases
pain
unspecified adult solid tumor, protocol specific
stage IV melanoma
stage IV renal cell cancer

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Carcinoma, Renal Cell
Kidney Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014