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

Stopped early · Phase 3

Conditions studied: Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00540969

Run by

Alliance for Clinical Trials in Oncology

People needed

3

Starts

2008-02-01

Expected to finish

2010-01-01

Last updated by the study team

2018-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Medical College of Wisconsin Cancer Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.