Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

NCT ID: NCT02304445

Last Updated: 2015-11-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transarterial Chemoembolization (TACE)

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

Group Type: ACTIVE_COMPARATOR

Transarterial Chemoembolization (TACE)

Intervention Type: PROCEDURE

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.

TACE+Stereotactic Body Radiotherapy

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

Group Type: EXPERIMENTAL

Transarterial Chemoembolization (TACE)

Intervention Type: PROCEDURE

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.

TACE+Stereotactic Body Radiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juan Sanabria, MD

OTHER

Sponsor Role: lead

Responsible Party

Juan Sanabria, MD

Physician Surgical Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juan Sanabria, MD

Role: PRINCIPAL_INVESTIGATOR

Midwestern Reginal Medical Center

Other Identifiers

MZ2014022

Identifier Type: -

Identifier Source: org_study_id