This phase I trial studies the side effects and the best dose of radiation therapy in treating patients with hepatocellular carcinoma, cholangiocarcinoma, or cancer that has spread from the original (primary) tumor to the liver who also have impaired liver function (liver damage caused by cirrhosis, chemotherapy, or surgery). Radiation therapy (RT) uses high energy x-rays to kill tumor cells and shrink tumors. New methods of giving RT to the liver may help control cancer.
PRIMARY OBJECTIVES: I. To evaluate the safety of high dose radiotherapy in patients who have liver tumors (hepatocellular carcinoma \[HCC\]/cholangiocarcinoma/liver metastases from any primary) and who have impaired liver function or low functional liver volume or who have received prior liver radiation. SECONDARY OBJECTIVES: I. To evaluate 2 year local control with radiotherapy in these patients. II. To evaluate tumor response, patterns of failure, and survival in these patients. III. To evaluate imaging- and serum-based biomarkers in these patients, as correlates of hepatic toxicity and tumor response. OUTLINE: This is a dose-escalation study. Patients undergo radiation therapy 5 days a week for a total of 15 or 25 fractions in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4-8 weeks and then every 3-4 months for 2 years. Patients who progress during the two year follow-up period are followed up every 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Correlative studies
Correlative studies
Undergo radiation therapy
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
Maximum dose constraint
Defined as the highest level dose constraint at which no more than 1 of 6 evaluable patients has had a dose limiting toxicity. Toxicities will be summarized with frequency by type, severity and their relationship to the treatment.
Time frame: 4-8 weeks after completion of radiation therapy
Local disease control rate
The Kaplan Meier method will be used to estimate 2-year local disease control rate.
Time frame: Up to 2 years
Tumor response
Will be observed.
Time frame: Up to 2 years
Patterns of failure
Will be observed.
Time frame: Up to 2 years
Overall survival
The Kaplan Meier method will be used to estimate the probability of overall survival.
Time frame: Up to 2 years
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