Liver Cancer
Conditions
Brief summary
This is a research study to evaluate change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30), from baseline to 1 month post treatment in two patient cohorts receiving Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy.
Interventions
OTHERQuality of life questionnaires
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria 10) by CT or MRI * Patient is 18 years or older * ECOG Performance status of 0-2 * Child Pugh score A5, A6, B7 or B8 (see Appendix) * Lesion ≤ 5cm in size * ≤ 3 lesions in the liver to be treated on protocol * Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.
Exclusion criteria
* Child Pugh score B9 or Class C * Fluctuating ascites * Inability to complete baseline Quality of Life survey forms * Concurrent administration of systemic therapy for hepatocellular carcinoma * Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy | baseline, 1 month, 3 months, 6 months | as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) measured from not at all (better) to very much (worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT | baseline, 1 month, 3 months, 6 months | as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse) |
| number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy | 90 days | — |
| number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy | 90 days | — |
| total healthcare system cost associated with Interventional Radiology Liver Directed Therapies | 90 days | — |
| total healthcare system cost associated with Hypofractionated Liver Directed Therapy | 90 days | — |
Countries
United States
Contacts
Primary ContactHeather Franklin
Backup ContactLinda Kaltenbach, PhD
Outcome results
None listed