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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
To determine the maximally tolerated dose
Time frame: From start of treatment to 90 days
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