Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer (TACE-SBRT)

Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)

This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.

Study Overview

• Status: Withdrawn
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Procedure: Transarterial Chemoembolization (TACE); Radiation: TACE+Stereotactic Body Radiotherapy

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hepatocellular carcinoma (Barcelona Stage B or C)
• Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment
• Age ≥ 18 years and ≤ 70 years
• Eastern Cooperative Oncology Group Performance status ≤ 2
• Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
• Hemoglobin > 10.0 g/dL
• Total bilirubin > 3.0 mg/dL
• AST (SGOT) ≤ 3x institutional upper limit of normal
• ALT (SGPT) ≤ 3x institutional upper limit of normal
• Absolute neutrophil count ≥ 1,500/μl
• Platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated)
• Aggregate maximal dimension of liver tumors ≤ 8 cm
• Cirrhosis classified as Child Pugh Class A or B (score ≤ 7)
• Determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (MRI/CT scan) three months post final treatment
• Life expectancy ≥ 12 weeks
• Ability to understand study and provide legally effective written informed consent
• Women of child-bearing potential must have a negative test within 4 weeks to the start of the SBRT treatment and must not be pregnant or nursing a child
• Sexually active women must agree to use accepted forms of birth control throughout the study, which include abstinence, oral contraceptives (birth control pills), IUD, diaphragm with spermicide, Norplant, hormone injections, condoms with spermicide, or documentation of medical sterilization

Exclusion Criteria:

• History of abdominal radiation
• Cirrhosis classified as Child Pugh Class B with score ≥ 8
• Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
• Evidence of metastatic disease prior to registration
• Evidence of main portal vein thrombosis
• History of cardiac ischemia or stroke within 6 months prior to enrollment
• Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation
• History of sorafenib therapy within 21 days prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Transarterial Chemoembolization (TACE); Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated.	Procedure: Transarterial Chemoembolization (TACE); TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.
EXPERIMENTAL: TACE+Stereotactic Body Radiotherapy; Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments.	Procedure: Transarterial Chemoembolization (TACE); TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.; Radiation: TACE+Stereotactic Body Radiotherapy; This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response rate	Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor down staging	Incidence of down staging of stage B or C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months	3 and 6 months
Frequency of adverse events	Incidence of Grade 3 or 4 adverse events associated with SBRT for liver tumors	6 months
Incidence of local tumor progression	Incidence of local progression as demonstrated by radiological imaging (RECIST criteria)	6 months
Number of patients eligibility for liver transplantation	Number of patients achieving sufficient tumor response to attain eligibility for liver transplantation.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Determination of the number of subjects alive at 3 years following their final study treatment.	3 years

Collaborators and Investigators

• Sponsor: Juan Sanabria, MD
• Investigators: Principal Investigator: Juan Sanabria, MD, Midwestern Reginal Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ANTICIPATED): November 1, 2017
• Study Completion (ANTICIPATED): November 1, 2017

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (ESTIMATE): December 2, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 26, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Radiotherapy; Chemoembolization
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Estrogens, Non-Steroidal; Estrogens; Chlorotrianisene
• Other Study ID Numbers: MZ2014022