Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Interventional Radiology Liver Directed Therapies (ILDT) ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization. |
Other: Quality 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)
|
| Active Comparator: Hypofractionated Image-Guided Radiation Therapy (HIGRT) HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation. |
Other: Quality 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)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
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)
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Lesion ≤ 5cm in size
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≤ 3 lesions in the liver to be treated on protocol
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Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.
Exclusion Criteria:
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Child Pugh score B9 or Class C
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Durham Veterans Administration Health Care System (DVAHCS) | Durham | North Carolina | United States | 27705 |
| 2 | Duke Cancer Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Manisha Palta, MD, Duke Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00089525_1