Back to resultsA Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have hepatocellular carcinoma.
- Patients must not have extrahepatic cancer.
- Patients must not be eligible for a curative liver resection or have refused resection
- Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy.
- Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death).
- Patients must be 18 years of age or older.
- Patients must have adequate organ function.
- Patients must understand and be willing to sign an IRB (Institutional Review Board) approved informed consent form.
Exclusion Criteria:
- Patients with known allergies to intravenous iodinated contrast agents.
- Patients with a contraindication to contrast-enhanced MRI are excluded.
Sites / Locations
- Rogel Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adaptive Radiation Therapy
Arm Description
Outcomes
Primary Outcome Measures
The proportion of patients for whom the intended treatment was feasible
The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning.
Percentage of patients with change in Child Pugh score >= 2
Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT.
Median Time to Local Progression
The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals.
Secondary Outcome Measures
Median Time to Progression
Defined as the duration of time from start of treatment to time of progression.
Change in ALBI scores
Liver decompensation assessed by change in ALBI score > 0.5 from baseline.
Incidence of Grade 3 gastrointestinal (GI) bleeding toxicities
Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0.
Overall Survival
Overall survival (OS) is defined as the duration of time from start of treatment to death.
Full Information
NCT ID
NCT02460835
First Posted
May 28, 2015
Last Updated
August 9, 2023
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02460835
Brief Title
A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
Official Title
A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 26, 2016 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot single arm study with the primary endpoints of feasibility and preliminary estimates of safety and efficacy. This protocol builds on over 25 years of experience with high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the global radiation dose based on a patient's measured sensitivity to treatment. This current protocol uses functional imaging and specialized radiation planning techniques to spare highly functional portions of the liver to preserve function. The investigators feel this will further improve the safety and efficacy of RT for all patients by customizing treatments to each. If this approach is promising, the investigators will proceed to a phase II randomized study of standard versus spatially and dosimetrically adapted RT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive Radiation Therapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Adaptive Radiation Therapy
Primary Outcome Measure Information:
Title
The proportion of patients for whom the intended treatment was feasible
Description
The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning.
Time Frame
At end of treatment; up to ~3 months
Title
Percentage of patients with change in Child Pugh score >= 2
Description
Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT.
Time Frame
Baseline to approximately 6 months after initiation of SBRT
Title
Median Time to Local Progression
Description
The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Median Time to Progression
Description
Defined as the duration of time from start of treatment to time of progression.
Time Frame
24 months
Title
Change in ALBI scores
Description
Liver decompensation assessed by change in ALBI score > 0.5 from baseline.
Time Frame
Approximately 6 months
Title
Incidence of Grade 3 gastrointestinal (GI) bleeding toxicities
Description
Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0.
Time Frame
Approximately 6 months
Title
Overall Survival
Description
Overall survival (OS) is defined as the duration of time from start of treatment to death.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Incidence of Radiation Induced Liver Disease (RILD)
Description
RILD is a rare but serious side effect that will be summarized if it occurs.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have hepatocellular carcinoma.
Patients must not have extrahepatic cancer.
Patients must not be eligible for a curative liver resection or have refused resection
Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy.
Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death).
Patients must be 18 years of age or older.
Patients must have adequate organ function.
Patients must understand and be willing to sign an IRB (Institutional Review Board) approved informed consent form.
Exclusion Criteria:
Patients with known allergies to intravenous iodinated contrast agents.
Patients with a contraindication to contrast-enhanced MRI are excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Lawrence, M.D., Ph.D.
Organizational Affiliation
Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rogel Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
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