radiation therapy in treating patients with liver metastases

Conditions: Metastatic Cancer

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 i trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases.

objectives: primary * determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases. secondary * determine the failure patterns and survival of patients treated with this regimen. * correlate dose-volume characteristics with possible toxic effects of this regimen in these patients. * determine the local control rate within irradiated fields in patients treated with this regimen. outline: this is a multicenter, dose-escalation study. patients undergo highly conformal radiotherapy (hcr) to the liver once daily, 5 days a week, for 2 weeks. cohorts of 6 patients receive escalating doses of hcr until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. after completion of study treatment, patients are followed periodically for 3 years. projected accrual: a total of 18 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of 1 of the following: * histologically confirmed non-lymphoma liver metastases * new radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer and a previously negative ct scan, mri, or pet/ct scan of the liver * no more than 5 measurable lesions by contrast-enhanced liver ct scan, mri, or pet/ct scan * liver metastases ≤ 8 cm * medically unfit for surgery or lesions are surgically unresectable * all intrahepatic disease must be encompassed within the study radiation field * extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting * at least 1,000 cc of normal liver * no clinical ascites * no cns metastases patient characteristics: performance status * zubrod 0-1 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,800/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 8 g/dl (transfusion allowed) hepatic * no active hepatitis * no clinically significant liver failure * no underlying cirrhosis renal * not specified cardiovascular * no congestive heart failure requiring hospitalization within the past 6 months * no unstable angina pectoris requiring hospitalization within the past 6 months * no transmural myocardial infarction within the past 6 months pulmonary * no chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis * no acute bacterial or fungal infection requiring iv antibiotics prior concurrent therapy: chemotherapy * at least 4 weeks since prior chemotherapy * no concurrent chemotherapy * no anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy) radiotherapy * no prior radiotherapy to the region of study * no concurrent intensity-modulated radiotherapy surgery * prior liver resection or ablative therapy allowed other * no concurrent warfarin or iv heparin

Keywords: liver metastases