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

NCT03168152 | Withdrawn DMC

• 2 other identifiers: UMCC 2017.001HUM00124501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of gastrointestinal (GI) and hepatobiliary toxicity

  Patients will be followed up to 2 years

• Incidence of liver function worsening

  Patients will be followed up to 2 years

• Change in FACT- Hep questionnaire score

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

• Overall survival time

  Patients will be followed up to 2 years

• Progression free survival time

  Patients will be followed up to 2 years

Study Arms (2)

MWA

EXPERIMENTAL

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

Radiation: Microwave Ablation (MWA)

SBRT

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Microwave Ablation (MWA) RADIATION

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

MWA

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dawn Owen, M.D., Ph.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: May 11, 2017
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

US (1)