Phase III Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Canadian Cancer Trials Group
- Enrollment
- 66
- Locations
- 7
- Primary Endpoint
- Proportion of Patients Achieving Significant Improvement of Liver Cancer Pain/Discomfort
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A diagnosis of cancer by at least one criterion listed below:
- •Pathologically or cytologically proven carcinoma from primary site or site of metastases;
- •Pathologically or cytologically proven HCC;
- •HCC diagnosed by standard imaging criteria: arterial enhancement and delayed washout on multiphasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis.
- •Largest burden of cancer in the liver is confirmed with CT scan or MRI corresponding to the clinically painful area done within 120 days prior to randomization.
- •Diffuse (infiltrative involving \> 50% of the liver), multifocal (\> 10 lesions) or locally advanced cancer (at least one lesion \> 10cm, vascular invasion, or multiple lesions with at least one \> 6cm) involving the liver.
- •In the investigator's opinion, patient is unsuitable for or refractory to standard local and regional therapies. For example:
- •HCC unsuitable for resection, radiofrequency ablation (RFA), transarterial chemo embolization (TACE) or radical intent, ablative dose stereotactic body radiation therapy (SBRT);
- •Colorectal carcinoma metastases unsuitable for resection, RFA or radical intent, ablative dose SBRT (e.g. SBRT, \> 30 Gy in 5 fractions, may be an option for up to 3 metastases \< 5cm each, or up to 5 metastases \< 3 cm each).
- •Unsuitable for, high risk for, or refractory to, standard systemic chemotherapy or targeted therapy (e.g. sorafenib).
Exclusion Criteria
- •Prior radiotherapy to the upper abdomen that would result in substantial overlap of the irradiated volume (e.g. \> 50% of liver receiving \> 24 Gy in 2 Gy equivalent dose);
- •Prior selective internal radiotherapy directed to the liver or hepatic arterial yttrium therapy, at any time.
- •Cholangitis or acute bacterial infection requiring intravenous antibiotics within 28 days prior to study entry.
- •Radiographic evidence of intrabiliary cancer within the common or main branches of the biliary system, \< 4 months prior to randomization.
- •Child-Pugh score greater than C10 (a score of C10 is allowed).
- •Chemotherapy or TACE administered within the past 4 weeks.
- •Targeted therapy (e.g. Sorafenib) received within the past 2 weeks.
- •Plans for chemotherapy, targeted therapy or TACE in the next 4 weeks.
Outcomes
Primary Outcomes
Proportion of Patients Achieving Significant Improvement of Liver Cancer Pain/Discomfort
Time Frame: 30 days
• Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points in pain "intensity at worst " on Brief Pain Inventory (BPI) from baseline to day 30.
Secondary Outcomes
- Proportion of Patients Alive at Day 90.(90 days)
- Proportion of Patients Achieving a 25% Reduction in Opioid Use at 30 Days (Employing Daily Morphine Equivalence Scale).(30 days)
- 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.(30 days)