A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

NCT ID: NCT02460835

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-26
• Study Completion Date: 2022-01-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adaptive Radiation Therapy

Group Type: EXPERIMENTAL

Adaptive Radiation Therapy

Intervention Type: RADIATION

Interventions

Adaptive Radiation Therapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Lawrence, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rogel Cancer Center

Locations

Rogel Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00098022

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2015.039

Identifier Type: -

Identifier Source: org_study_id