Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma

NCT ID: NCT03168152

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-11
• Study Completion Date: 2022-04-01

Brief Summary

This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).

This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which local ablative modality is most appropriate for which patients. This study will also provide important information regarding quality of life and liver function changes following these two different treatment modalities.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MWA

MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.

Group Type: EXPERIMENTAL

Microwave Ablation (MWA)

Intervention Type: RADIATION

MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.

SBRT

SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.

Interventions

Microwave Ablation (MWA)

MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.

Intervention Type: RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients with hepatocellular carcinoma (HCC) are eligible for this trial. HCC is defined as having at least one of the following:

1. HCC diagnosed either on biopsy or based on standard imaging criteria on contrast enhanced CT or MRI (arterial enhancement with washout and pseudocapsule); or

2. A discrete hepatic tumor(s) as defined by the Barcelona criteria10 for cirrhotic patients, >1 cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI

3. Presentation at multidisciplinary liver tumor board to assess eligibility for either SBRT or MWA

• Patients must have 1-2 intrahepatic foci of HCC and may not be candidates for refuse hepatic resection. Patients who are on the organ wait list for (orthotopic liver transplantation) OLT will be considered for this trial as a "bridge" to transplant.
• Patients with 1 focus of HCC will be eligible if their tumor is 3.5 cm or less in greatest diameter. Patients with 2 foci of HCC will be eligible if each lesion is 3.5 cm in diameter or less and the combined diameter of both lesions is 5 cm or less.
• The foci of HCC must be in an anatomic location amendable to treatment by both MWA and SBRT.
• The patient must have an ECOG performance status of ≤ 2 (Eastern Cooperative Oncology Group Performance Status is an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death).
• Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, MWA or TACE) and a minimum of 4 weeks must have passed since the last procedure and protocol therapy.
• Patients must have:

1. Platelets ≥ 50,000/mm3

2. Child Pugh class A liver function or class B7 (Appendix II)

3. INR (international normalized ratio (for anticoagulant monitoring)) < 1.5

• The patient must have a life expectancy of at least 12 weeks
• The patient must be at least 18 years old
• Patients must sign an IRB approved informed consent form for this purpose indicating that they are aware of the investigational aspects of the treatment and the potential risks. They also must be able to understand and the willing to sign a written informed consent.

Exclusion Criteria

• Patients who have received prior abdominal radiation
• Patients with 3 or more foci of HCC
• Patients whose HCC involves the local vasculature, regional lymph nodes or distant metastatic sites
• Patients with Child Pugh liver function worse than B7

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

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn Owen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00124501

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2017.001

Identifier Type: -

Identifier Source: org_study_id