Clinical trial NCT03168152: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to local tumor progression
timeFrame: Patients will be followed up to 2 years
Secondary outcomes:
measure: Incidence of gastrointestinal (GI) and hepatobiliary toxicity
timeFrame: Patients will be followed up to 2 years
measure: Incidence of liver function worsening
timeFrame: Patients will be followed up to 2 years
measure: Change in FACT- Hep questionnaire score
timeFrame: Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
measure: Overall survival time
timeFrame: Patients will be followed up to 2 years
measure: Progression free survival time
timeFrame: Patients will be followed up to 2 years
measure: Metastasis free survival time
timeFrame: Patients will be followed up to 2 years
measure: Incidence of intrahepatic failure
timeFrame: Patients will be followed up to 2 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Dawn Owen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: