NCT02626312

Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function

Phase I Trial of Radiation Therapy in Patients With Liver Cancers and Impaired Liver Function

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cholangiocarcinoma
• Cirrhosis
• Hepatocellular Carcinoma
• Metastatic Malignant Neoplasm in the Liver

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Correlative studies
RADIATION	Radiation Therapy	Undergo radiation therapy
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2016-02-15
• Primary completion: 2026-04-28
• Completion: 2026-04-28
• First posted: 2015-12-10
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study