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

Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

Sponsors

Lead sponsor: Juan Sanabria, MD

Source Midwestern Regional Medical Center
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.

Overall Status Withdrawn
Start Date November 2015
Completion Date November 2017
Primary Completion Date November 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Tumor response rate 3 months
Secondary Outcome
Measure Time Frame
Tumor down staging 3 and 6 months
Frequency of adverse events 6 months
Incidence of local tumor progression 6 months
Number of patients eligibility for liver transplantation 3 months
Condition
Intervention

Intervention type: Procedure

Intervention name: Transarterial Chemoembolization (TACE)

Description: 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.

Intervention type: Radiation

Intervention name: TACE+Stereotactic Body Radiotherapy

Description: 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.

Arm group label: TACE+Stereotactic Body Radiotherapy

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Juan Sanabria, MD Principal Investigator Midwestern Reginal Medical Center
Verification Date

November 2015

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Juan Sanabria, MD

Investigator title: Physician Surgical Oncology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Transarterial Chemoembolization (TACE)

Arm group type: Active Comparator

Description: Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated.

Arm group label: TACE+Stereotactic Body Radiotherapy

Arm group type: Experimental

Description: Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments.

Acronym TACE-SBRT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov