Cryoablation or External-Beam Radiation Therapy in Treating Patients With Painful Bone Metastases
Condition: Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Melanoma; Neoplasm Metastasis; Kidney Neoplasms
Intervention: cryosurgery; radiation therapy
Intervention description: Patients undergo cryosurgery using guidance from CT scan or ultrasound; Patients undergo radiotherapy for 1 week
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bone metastases; pain; unspecified adult solid tumor, protocol specific; stage IV melanoma; stage IV renal cell cancer

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.
    

Eligibility 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