A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases

Inclusion 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