Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain
Condition: Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Melanoma; Sarcoma; Neoplasm Metastasis; Kidney Neoplasms
Intervention: questionnaire administration; 3-dimensional conformal radiation therapy; hypofractionated radiation therapy; image-guided radiation therapy; tomotherapy
Intervention description: Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.; Conformal radiation therapy improves the ability to spare normal tissues.; Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.; Image guided radiation therapy targets the specific site of disease.; Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: unspecified adult solid tumor, protocol specific; recurrent adult soft tissue sarcoma; recurrent melanoma; recurrent osteosarcoma; recurrent renal cell cancer; recurrent uterine sarcoma; stage IV adult soft tissue sarcoma; stage IV melanoma; stage IV uterine sarcoma; ovarian sarcoma; chondrosarcoma; metastatic osteosarcoma; stage IV renal cell cancer; lung metastases; liver metastases; bone metastases

Summary:

      RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
      the tumor may kill more tumor cells and cause less damage to normal tissue.

      PURPOSE: This phase II trial is studying how well conformal radiation therapy works in
      treating patients with metastatic cancer outside the brain.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed cancer

               -  No active disease at the primary site as assessed by physical examination,
                  clinical evaluation, or site-specific imaging

          -  Measurable metastatic disease meeting the following criteria:

               -  Four or fewer sites of extracranial lesions < 5 cm in size

               -  If metastatic site(s) is within the lung, the following criteria must be met:

                    -  No more than two metastases in the proximal bronchial tree area (defined as
                       2 cm from the trachea or mainstem bronchi)

                    -  Carbon monoxide diffusing capacity (DLCO) > 30% predicted and forced
                       expiratory volume 1 (FEV1) > 1.2 L (in patients with more than one
                       metastatic site in the lungs)

               -  If metastatic site(s) is within 2 cm of either kidney, creatinine level must be <
                  1.5 times upper limit of normal (ULN)

               -  If metastatic site(s) is within 2 cm of the liver, bilirubin level must be < 1.5
                  times ULN

          -  Patients with metastatic disease that meets any of the following criteria are
             excluded:

               -  Proposed site(s) of treatment has been previously treated with radiotherapy

               -  Metastatic site(s) requires emergent treatment (e.g., spinal cord compression,
                  cauda equina, airway compromise, or life-threatening end-organ dysfunction)

               -  Disease that is untreated or previously treated and progressive in the brain

               -  Pathologic fracture or impending pathologic fracture at the metastatic site

               -  Metastatic site(s) of a disease histology that is known to be sensitive to low
                  doses of radiotherapy (e.g., pure seminoma, lymphoma, or small cell carcinoma)

          -  Patients in whom surgery is deemed an appropriate option as standard of care (e.g.,
             isolated lung metastasis from sarcoma or isolated liver metastasis from colon cancer)
             but who refuse surgical therapy are eligible

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy > 12 weeks as assessed by the consulting radiation oncologist

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of lupus erythematosus or scleroderma

          -  No known hypersensitivity to therapeutic radiotherapy

          -  No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ
             malignancies of the cervix, bladder, or head and neck

          -  No unrelated systemic illness that, in the judgment of the investigator, would
             compromise the patient's ability to tolerate study therapy or would likely interfere
             with study procedures or results

          -  Able or likely to adhere to study treatment

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 2 weeks since prior and no concurrent chemotherapy

          -  Prior or concurrent hormonal agents, including antiandrogens, gonadotropin-releasing
             hormone agonists, aromatase inhibitors, tamoxifen, or similar agents allowed

          -  No change in systemic therapy for 6 weeks before or within 4 weeks after initiating
             study radiotherapy