INCLUSION CRITERIA:
Histological diagnosis:
1. Pathologically confirmed diagnosis of cancer.
2. Four or fewer sites of measurable metastatic disease that meet the
following criteria:
-The lesions are extra-cranial.
-Each lesion measures less than 5cm.
-If metastatic site(s) within lung.
--No more than 2 metastasis in the proximal bronchial tree area (defined as 2 cm from the trachea or mainstem bronchi).
--Patients with more than one metastatic site in the lungs must have a DLCO > 30% predicted and FEV1 > 1.2 L.
- If metastatic site(s) within 2 cm of either kidney, patient must have a creatinine less than 1.5 x the upper limit of normal.
- If metastatic site(s) within 2 cm of the liver must have a bilirubin less than 1.5 x the upper limit of normal.
Patients must be older than 18 years of age.
Patients have an ECOG performance status of 0, 1, or 2.
Patients have a life expectancy of greater than 12 weeks as assessed by the consulting radiation oncologist.
Patients in whom surgery is deemed an appropriate option as standard of care but refuse surgical therapy (for example isolated lung metastasis from sarcoma or isolated liver metastasis from colon cancer) are eligible.
Patients must have a primary medical or surgical oncologist in the community or at NCI who is wiling to collaborate with the ROB staff in the clinical management of the patient.
Patients of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
EXCLUSION CRITERIA:
Active disease at the primary disease site as assessed by physical examination, clinical evaluation, or site specific imaging.
Patients whose metastatic site(s) of disease meet any of the following criteria:
-Proposed site(s) of treatment have previously been treated with radiation.
-Metastatic site(s) requiring emergent treatment (spinal cord compression, cauda equina compression. Airway compromise, life threatening end organ dysfunction).
-Untreated or previously treated and progressive metastatic disease in the brain.
-Pathologic fracture or impending pathologic fracture at the metastatic site(s).
-Metastatic site(s) are of a disease histology known to be sensitive to low doses of radiation: pure seminoma, lymphoma, small cell carcinoma.
Prior therapy
- Patients who have received chemotherapy within 2 weeks of enrollment (not including hormonal agents such as antiandrogens, GnRH agonists, aromatase inhibitors, tamoxifen, and similar agents).
- Patients who have experienced a change in systemic therapy within 6 weeks before or anticipated within 4 weeks after commencing radiotherapy.
Patients with a history of lupus erythematosis, scleroderma, or other known hypersensitivity to therapeutic radiation.
Patients with a concurrent second malignancy other than nonmelanoma skin cancer or in situ malignancies of the cervix, bladder, or head and neck.
Patients with a diagnosis of a second malignancy with disease control duration less than 2 years.
Patients who are pregnant or breast-feeding females because of the potential mutagenic effects on a developing fetus or newborn.
Patients with unrelated systemic illness which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results.
Patients who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/20/2008