A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460835
• Other study ID #: UMCC 2015.039
• Secondary ID: HUM00098022
• Status: Completed
• Phase: N/A
• Start date: January 26, 2016
• Est. completion date: January 20, 2022

Study information

• Verified date: November 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Adaptive Radiation Therapy

Locations

Country	Name	City	State
United States	Rogel Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Radiation Induced Liver Disease (RILD)	RILD is a rare but serious side effect that will be summarized if it occurs.	24 months
Primary	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.	At end of treatment; up to ~3 months
Primary	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.	Baseline to approximately 6 months after initiation of SBRT
Primary	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.	24 months
Secondary	Median Time to Progression	Defined as the duration of time from start of treatment to time of progression.	24 months
Secondary	Change in ALBI Scores	Liver decompensation assessed by change in ALBI score > 0.5 from baseline.	Approximately 6 months
Secondary	Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities	Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0.	Approximately 6 months
Secondary	Overall Survival	Overall survival (OS) is defined as the duration of time from start of treatment to death.	24 months