Radiation Therapy in Treating Patients With Liver Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radiation therapy dose level II: 4.0 Gy/fx<br>Radiation therapy dose level II: 4.0 Gy/fraction | Radiation: radiation therapy<br> <br> |
| Other: Radiation therapy dose level III: 4.5 Gy/fx<br>Radiation therapy dose level III: 4.5 Gy/fraction | Radiation: radiation therapy<br> <br> |
| Other: Radiation therapy dose level IV: 5.0 Gy/fx<br>Radiation therapy dose level IV: 5.0 Gy/fraction | Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximally tolerated dose |  | From start of treatment to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastases