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Investigator(s):
Deborah Citrin, M.D. Principal Investigator Phone: 301-496-5457 citrind@mail.nih.gov
Referral Contact(s):
Sharon L. Smith, R.N., M.S., O.C.N., C.C.R.P. Research Nurse Phone: 301-496-5457 Fax: 301-480-2347 smiths@mail.nih.gov

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Primary Eligibility:

• Pathologically confirmed cancer; no active disease at the primary site
• 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)
• DLCO > 30% predicted and FEV1 > 1.2 L (in patients with > one metastatic site in the lungs)
• If metastatic site(s) is within 2 cm of either kidney, creatinine level must be < 1.5 x upper limit of normal (ULN)
• If metastatic site(s) is within 2 cm of the liver, bilirubin level must be < 1.5 x ULN
• Patients with metastatic disease meeting 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
• > 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
• ECOG performance status 0–2
• Not pregnant or nursing; 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 illness that would preclude study participation

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Treatment Plan:

Patients are stratified according to histology (renal cell carcinoma vs melanoma vs sarcoma vs other histologies).

• Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of three fractions
• Patients undergo megavoltage imaging before and after each fraction to verify the positioning of each target lesion
• Patients complete a pain assessment questionnaire at baseline and at 1 and 3 months after treatment
• After completion of study therapy, patients are followed at 1 and 3 months and then every 3 months for up to 1 year

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/29/08
Updated: 11/14/08