A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

NCT02460835 | Completed Results DMC

• 2 other identifiers: UMCC 2015.039HUM00098022
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Median Time to Progression

  24 months

• Change in ALBI Scores

  Approximately 6 months

• Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities

  Approximately 6 months

• Overall Survival

  24 months

Other Outcomes (1)

• Incidence of Radiation Induced Liver Disease (RILD)

  24 months

Study Arms (1)

Adaptive Radiation Therapy

EXPERIMENTAL

Radiation: Adaptive Radiation Therapy

Interventions

Adaptive Radiation Therapy RADIATION

Adaptive Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with known allergies to intravenous iodinated contrast agents.
• Patients with a contraindication to contrast-enhanced MRI are excluded.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Rogel Comprehensive Cancer Center

Ann Arbor, Michigan, 48187, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr. Theodore Lawrence
• Organization: University of Michigan Rogel Cancer Center

tsl@umich.edu

734-647-9955

Study Officials

• Theodore Lawrence, M.D., Ph.D.

  Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: January 26, 2016
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-11

Locations

US (1)