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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03168152
• Other study ID #: UMCC 2017.001
• Secondary ID: HUM00124501
• Status: Withdrawn
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2018
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Radiation:
• Microwave Ablation (MWA)
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
• 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.

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patients will be followed up to 2 years
Secondary	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.	Patients will be followed up to 2 years
Secondary	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.	Patients will be followed up to 2 years
Secondary	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.	Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
Secondary	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.	Patients will be followed up to 2 years
Secondary	Progression free survival time	Progression Free Survival (PFS) is defined as the minimum time to death or any progression.	Patients will be followed up to 2 years
Secondary	Metastasis free survival time	Metastasis-free survival (MFS) is defined as the minimum time to development of metastases or death, whichever occurs first.	Patients will be followed up to 2 years
Secondary	Incidence of intrahepatic failure	Intrahepatic failure will include progression of the treated lesion(s) as well as development of other new liver lesions.	Patients will be followed up to 2 years