Protocol Title:

A Phase I Trial of Highly Conformal Radiation Therapy For Patients With Liver Metastases

Protocol Status:

Open

Protocol Number:

R-0438

Type of Cancer:

Metastatic Liver Cancer

Principal Investigator:

Joseph Herman, M.D.

Research Nurse:

Beth Griffith, R.N.

Phase Number:

I

General Eligibility:

Patients can be male or female of any race and greater than or equal to 18 years of age. Patients must have metastatic disease caused from liver cancer. Subjects must be medically unfit for surgery or have lesions that are surgically unresectable. All disease in the liver must be encompassed within the study radiation field. All disease outside the liver is allowed provided the liver disease is life-limiting. At least 1,000 cc of normal liver. No clinical ascites and no central nervous system metastases.

Purpose:

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.

Treatment:

This is a multi-center, 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.