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

DISEASE CHARACTERISTICS: Inclusion criteria:

• Histologically or cytologically confirmed solid tumor metastasis with index lesioninvolving or abutting bone

• Index lesion with bone destruction is predominantly osteolytic in nature asassessed on CT imaging

• If the nature of the metastatic disease has been previously documented, the indexlesion 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 intolerableside effects

• Tumor is appropriate for radiotherapy as determined by the participating radiationoncologist and accessible for cryoablation as determined by the participatingradiologists upon review of ultrasound, CT scan, X-ray, or MRI examinations

• Have completed chemotherapy, hormonal therapy, or bisphosphonate therapy ≥ 4 weeksprior to registration OR have developed pain or have persistent pain while on a stablechemotherapy, hormonal therapy, or bisphosphonate therapy regimen for a period of ≥ 4weeks

Exclusion criteria:

• Index lesion causing clinical or radiographic evidence of spinal cord or cauda equinacompression/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 inweight-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 beendiscontinued for an appropriate time period based on the drug half-life and knownactivity (e.g., aspirin for 7 days) for patients randomized to receive cryoablationonly

• Low molecular weight heparin preparations must be discontinued 8 hours prior tocryoablation

• At least 2 weeks since prior cytotoxic chemotherapy (for patients randomized toreceive 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 abdominalvessel such as the aorta or IVC, bowel, or bladder