Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

Not Applicable

Withdrawn

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: Transarterial Chemoembolization (TACE); Radiation: TACE+Stereotactic Body Radiotherapy

• Registration Number: NCT02304445
• Lead Sponsor: Juan Sanabria, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-12-02
• Status Verified: 2015-11
• Study Start: 2015-11
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-26
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transarterial Chemoembolization (TACE)	Transarterial Chemoembolization (TACE)	Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated.
TACE+Stereotactic Body Radiotherapy	TACE+Stereotactic Body Radiotherapy	Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments.
TACE+Stereotactic Body Radiotherapy	Transarterial Chemoembolization (TACE)	Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments.

Primary Outcome Measures

Name	Time	Method
Tumor response rate	3 months	Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months

Secondary Outcome Measures

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