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

Primary Purpose

Carcinoma, Hepatocellular

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Microwave Ablation (MWA)

Stereotactic Body Radiation Therapy (SBRT)

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MWA

SBRT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to local tumor progression

The primary outcome of this trial is to prospectively determine local control rates in patients with HCC treated with MWA or SBRT. Freedom From Local Progression (FFLP) is defined as the time from randomization to local tumor progression. Tumors falling to group PD (progressive disease) would constitute local control failures. Progressive disease will be defined as at least a 20% increase in the LD (longest diameter) of target lesion, taking as reference the smallest LD recorded. Or at least a 20% increase in viable arterial enhancing disease, taking as reference the smallest LD of viable HCC since treatment started. Increases of less than 3 mm compared to the smallest LD recorded will be considered stable disease rather than PD.

Secondary Outcome Measures

Incidence of gastrointestinal (GI) and hepatobiliary toxicity

The number of patients experiencing grade 3 or higher GI or hepatobiliary toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Incidence of liver function worsening

The number of patients experiencing a 2 point or more increase in Child-Pugh score and an increase in albumin-bilirubin score of at least 0.5.

Change in FACT- Hep questionnaire score

The FACT-Hep questionnaire is used to measure health-related quality of life (HRQoL) in patients with hepatobiliary cancers. They are asked questions about their physical, social, emotional and functional well-being and asked to provide a score between 0 and 4 where 0 represents not at all and 4 represents very much.

Overall survival time

Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at last follow-up will be censored on that date.

Progression free survival time

Progression Free Survival (PFS) is defined as the minimum time to death or any progression.

Metastasis free survival time

Metastasis-free survival (MFS) is defined as the minimum time to development of metastases or death, whichever occurs first.

Incidence of intrahepatic failure

Intrahepatic failure will include progression of the treated lesion(s) as well as development of other new liver lesions.

Full Information

NCT ID

NCT03168152

First Posted

May 17, 2017

Last Updated

June 20, 2018

Sponsor

University of Michigan Rogel Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03168152

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Withdrawn

Why Stopped

No patients were accrued to the trial

Study Start Date

May 11, 2017 (Actual)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MWA

Arm Type

Experimental

Arm Description

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

Arm Title

SBRT

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

Microwave Ablation (MWA)

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to local tumor progression

Description

Time Frame

Patients will be followed up to 2 years

Secondary Outcome Measure Information:

Title

Incidence of gastrointestinal (GI) and hepatobiliary toxicity

Description

The number of patients experiencing grade 3 or higher GI or hepatobiliary toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Time Frame

Patients will be followed up to 2 years

Title

Incidence of liver function worsening

Description

The number of patients experiencing a 2 point or more increase in Child-Pugh score and an increase in albumin-bilirubin score of at least 0.5.

Time Frame

Patients will be followed up to 2 years

Title

Change in FACT- Hep questionnaire score

Description

Time Frame

Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment

Title

Overall survival time

Description

Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at last follow-up will be censored on that date.

Time Frame

Patients will be followed up to 2 years

Title

Progression free survival time

Description

Progression Free Survival (PFS) is defined as the minimum time to death or any progression.

Time Frame

Patients will be followed up to 2 years

Title

Metastasis free survival time

Description

Metastasis-free survival (MFS) is defined as the minimum time to development of metastases or death, whichever occurs first.

Time Frame

Patients will be followed up to 2 years

Title

Incidence of intrahepatic failure

Description

Intrahepatic failure will include progression of the treated lesion(s) as well as development of other new liver lesions.

Time Frame

Patients will be followed up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: HCC diagnosed either on biopsy or based on standard imaging criteria on contrast enhanced CT or MRI (arterial enhancement with washout and pseudocapsule); or 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 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: Platelets ≥ 50,000/mm3 Child Pugh class A liver function or class B7 (Appendix II) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

University of Michigan Rogel Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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