A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
- Determine the maximum tolerated dose of high dose per fraction, highly conformal
radiotherapy in patients with liver metastases.
- Determine the failure patterns and survival of patients treated with this regimen.
- Correlate dose-volume characteristics with possible toxic effects of this regimen in
- Determine the local control rate within irradiated fields in patients treated with this
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximally tolerated dose
From start of treatment to 90 days
Alan W. Katz, MD
James P. Wilmot Cancer Center
United States: Federal Government
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|