TACE With or Without Radiation Therapy in Treating Patients With Stage A-C Liver Cancer

NCT ID: NCT02070419

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-11-30

Brief Summary

This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. TACE involves reaching up to the blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that delivers radiation to the tumor cells but does not harm normal liver cells. It is not yet known whether TACE is more effective with or without SBRT in treating liver tumors.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine in patients with stage A to C hepatocellular carcinoma, if stereotactic body radiotherapy after TACE enhanced the response rate of hepatocellular carcinoma (HCC) when compared to TACE alone at 3 months.

SECONDARY OBJECTIVES:

I. To determine in patients with stage A to C hepatocellular carcinoma, if TACE plus SBRT can achieve a downstaging rate of >= 30% at 3 and 6 months.

II. To determine the rate of grade 3 or 4 adverse events associated with SBRT for liver tumors.

III. To determine the rate of local progression after SBRT. (Based on Response Evaluation Criteria in Solid Tumors [RECIST] criteria) IV. Number of patients who achieve liver transplantation. V. Overall survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms after the first loco-regional therapy with TACE.

ARM I: Patients undergo TACE according to institutional standard with doxorubicin-eluting beads.

ARM II: Patients undergo TACE as in Arm I and 3 or 5 fractions of SBRT given at least 48 hours apart over 14 days.

After completion of study treatment, patients are followed up at 1, 3, and 6 months and then periodically thereafter.

Conditions

Adult Primary Hepatocellular Carcinoma; Recurrent Adult Primary Liver Cancer; Stage I Adult Primary Liver Cancer; Stage II Adult Primary Liver Cancer; Stage IIIA Adult Primary Liver Cancer

Study Design

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

Study Groups

Arm I (TACE)

Patients undergo (transarterial chemoembolization) TACE according to institutional standard with doxorubicin-eluting beads.

Group Type: ACTIVE_COMPARATOR

transarterial chemoembolization

Intervention Type: PROCEDURE

Undergo TACE with doxorubicin-eluting beads

Arm II (TACE+SBRT)

Patients undergo transarterial chemoembolization (TACE) as in Arm I and 3 or 5 fractions of stereotactic radiosurgery (SBRT) given at least 48 hours apart over 14 days.

Group Type: EXPERIMENTAL

transarterial chemoembolization

Intervention Type: PROCEDURE

Undergo TACE with doxorubicin-eluting beads

stereotactic radiosurgery

Intervention Type: RADIATION

Undergo SBRT

Interventions

transarterial chemoembolization

Undergo TACE with doxorubicin-eluting beads

Intervention Type: PROCEDURE

stereotactic radiosurgery

Undergo SBRT

Intervention Type: RADIATION

Other Intervention Names

TACE

Eligibility Criteria

Inclusion Criteria

• HCC is staged as Barcelona A to C
• Treatment with SBRT can occur within 6 weeks of registration
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Patient has

• Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or
• Histological confirmation of HCC as determined by the Liver Tumor Board
• Hemoglobin greater than 10.0 g/dL
• Total bilirubin less than 3.0 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 X institutional upper limit of normal
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal
• Total aggregate of maximal dimension of liver tumors is =< 8 cm
• Cirrhotic patients Child Pugh class A or B (score =< 7)
• Patient must be determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (magnetic resonance imaging [MRI]/computed tomography [CT] scan) three months post final treatment
• Absolute neutrophil count >= 1,500/μl
• Platelet count >= 50,000 μl (after transfusion if required)
• Life expectancy > 12 weeks
• Subjects must have the ability to understand and be willing to provide written informed consent
• Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
• Women must not be pregnant or nursing
• Sexually active women must agree to use accepted forms of birth control; acceptable options for birth control will be documented in the consent and discussed with the subject prior to enrollment

Exclusion Criteria

• Patient with previous history of abdominal radiation
• Cirrhotic patients 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 known cardiac ischemia or stroke within last 6 months
• Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Sanabria

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Other Identifiers

NCI-2014-00246

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE2212

Identifier Type: -

Identifier Source: secondary_id

CASE 2212

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE2212

Identifier Type: -

Identifier Source: org_study_id