Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality of life questionnaires.
- Who it may be relevant to
- Registry conditions: Liver Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Non-Randomized Trial of Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
Overview
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
- 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)
Primary outcome measures
- change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy [Time frame: baseline, 1 month, 3 months, 6 months]
Secondary outcome measures (5)
- change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT [Time frame: baseline, 1 month, 3 months, 6 months]
- number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy [Time frame: 90 days]
- number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy [Time frame: 90 days]
- total healthcare system cost associated with Interventional Radiology Liver Directed Therapies [Time frame: 90 days]
- total healthcare system cost associated with Hypofractionated Liver Directed Therapy [Time frame: 90 days]
Eligibility 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Durham Veterans Administration Health Care System (DVAHCS) — Durham
- Duke Cancer Center — Durham
Identifiers
NCT: NCT04933435 · Pro00089525_1