Study of Palliative Radiation Therapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases

Official Title

Phase III Study of Palliative Radiation Therapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases

Summary:

The purpose of this study is to see whether one dose of palliative radiation therapy directed to the liver in combination with standard BSC might help to reduce liver pain/discomfort due to cancer when compared to getting standard BSC alone.

Trial Description

Primary Outcome:

• Proportion of patients achieving improvement of liver cancer pain/discomfort

Secondary Outcome:

• Proportion of patients experiencing grade ≥ 2 adverse events at day 30 and day 90
• Proportion of patients alive at day 90.
• Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points from baseline to day 30 and day 90 in all BPI pain scores.
• Proportion of patients reporting clinically significant improvement in QoL from baseline to day 30 and day 90
• Proportion of patients achieving a 25% reduction in opioid use at 30 days (employing daily morphine equivalence scale).
• Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points in pain "intensity at worst " AND with no increase in opioid use (employing daily morphine equivalence scale) on BPI from baseline to 30 days.
• Proportion of patients reporting clinically significant improvement in QoL from baseline to day 30 and day 90
• Proportion of patients reporting clinically significant improvement in QoL from baseline to day 30 and day 90

The standard treatment for liver cancer pain or discomfort like yours is known as best supportive care (BSC) and includes pain-relieving medicines called analgesics. This type of treatment can help in some cases; however, some analgesics require a healthy liver to work properly. This means that there are many patients who have a hard time managing their liver cancer pain/discomfort with BSC alone. Sometimes radiation therapy is given in the "palliative" setting meaning it is designed to treat the pain/discomfort and not necessarily to shrink or eliminate the tumour. Palliative radiation therapy is often given when patients have painful bone tumours, but is not yet widely used to treat liver pain/discomfort. Palliative radiation therapy is usually given in smaller amounts and less frequently than other kinds of radiation therapy.

View this trial on ClinicalTrials.gov