Clinical trial NCT04933435: Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
timeFrame: baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT
timeFrame: baseline, 1 month, 3 months, 6 months
measure: number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
timeFrame: 90 days
measure: number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
timeFrame: 90 days
measure: total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
timeFrame: 90 days
measure: total healthcare system cost associated with Hypofractionated Liver Directed Therapy
timeFrame: 90 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Veterans Administration Health Care System (DVAHCS)
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Manisha Palta, MD
role: PRINCIPAL_INVESTIGATOR
References: