Clinical trial NCT03338062: A Pilot Study to Assess Theragnostically Planned Liver Radiation to Optimize Radiation Therapy
Official title: A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Hepatocellular Carcinoma
Cholangiocarcinoma
Keywords: Radiation Treatment
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.


Eligibility criteria: Inclusion Criteria

* Subjects must be ≥ 18 years of age at the time of signing informed consent
* Diagnosis of primary liver malignancy (including hepatocellular carcinoma \[HCC\] or cholangiocarcinoma) or liver metastasis from any primary solid tumor site by characteristic imaging findings on CT or MRI, clinical presentation, and/or pathologic confirmation of diagnosis.
* Subjects with other current or prior malignancies are eligible for this study.
* Patients with liver metastases must have at least one of the following clinical factors that may affect liver function:

  1. History of liver resection (at any time)
  2. History of cirrhosis (any cause), fatty liver disease, or hepatic insufficiency due to any cause
  3. Prior radiation to the upper abdomen including radioembolization
* ECOG (Zubrod) Performance Status 0-2.
* Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible.
* Patients who have been previously treated with non-SBRT liver directed therapies may be enrolled on study. At least 3 months must have elapsed between the most recent liver-directed therapy and study entry.
* Ability to provide written informed consent and HIPAA authorization
* Subjects with an allergy to contrast agents may be enrolled at the treating physician's discretion with appropriate pre-treatment and symptom management.

Exclusion Criteria

* Subjects who are pregnant or planning to become pregnant during the study. Women of child bearing potential must have a negative pregnancy test
* Subjects must not have received chemotherapy within 2 weeks of planned 1st day of RT.
* No more than 3 lesions may be treated. The maximum sum of the diameter(s) of the lesion(s) must be ≤6 cm
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would in the opinion of the investigator limit compliance with study requirements

Primary outcomes:
measure: Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
timeFrame: Day -1 of Radiation Treatment
Secondary outcomes:
measure: Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan
timeFrame: Day -1 of Radiation Treatment
measure: Duration of Local Control
timeFrame: Up to 15 months
measure: Progression Free Survival
timeFrame: Up to 15 months
measure: Overall Survival
timeFrame: Up to 3 years
measure: Time to Transplant
timeFrame: Up to 15 months
measure: Time to Distant Liver Failure
timeFrame: Up to 15 months
measure: Time Until Salvage Treatment
timeFrame: Up to 15 months
measure: Number of Patients With Treatment-Related Adverse Events Grade 3 or Above
timeFrame: Every 15 days for approximately 6 months
measure: Change in MELD Score
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Ryan M Rhome, MD
role: PRINCIPAL_INVESTIGATOR
References: