A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma

NCT ID: NCT01247298

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-12-31

Brief Summary

This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.

Detailed Description

Primary objectives of this research

1. Evaluate the safety of a combination of TACE and high dose SBRT

2. Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE & SBRT.

Secondary objectives of this research

1. Assess failure patterns and survival of patients treated with TACE & SBRT.

2. Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic Body Radiation Therapy (SBRT)

Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: COMBINATION_PRODUCT

This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.

Interventions

Stereotactic Body Radiation Therapy (SBRT)

This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

TACE

Eligibility Criteria

Inclusion Criteria

Diagnosis

Patients meeting all the following criteria will be considered for enrollment:

• Pathologically confirmed HCC -OR
• HCC greater than 2 cm with classic radiographic findings on 2 separate testing modalities, or an HCC greater than 2 cm with a serum alpha feto-protein greater than 200.

Lesions:

Single liver lesion: measuring 3 cm to ≤ 8 cm*.

• Multiple liver lesions: ≤ 3 liver lesions, none measuring over 5 cm, provided all lesions are considered for TACE.
• Lesions <3 cm if they are in an unfavorable location for ablation† *The size criteria of hepatic lesions are also subjected to the dose volume constraints for radiotherapy, as described below.

Patient

• Patient deemed to not candidate or should have refused liver-transplant, surgery or RFA.
• Patient must be a candidate and receive TACE.
• ECOG (Eastern Cooperative Oncology Group) Zubrod Performance Scale = 0-1.
• Age > 19
• Patient should not be pregnant. Women of childbearing potential and male participants must practice adequate contraception.

Adequate hematological profile and adequate liver functions. Signed informed consent document

Imaging studies completed at least 60 days prior to study entry. Evaluated by radiation oncologist within 2 weeks prior to study entry.

Exclusion Criteria

Patients presenting with any of the following will not be included in the study:

1. Prior invasive malignancies

2. Prior radiotherapy to the liver or surrounding areas.

3. Systemic therapy using any chemotherapy and/or targeted agents given within 2 weeks prior to TACE, during RT, and / or within 3 weeks following RT

4. Severe medical co-morbidities

5. INR (international normalized ratio) > 2 times upper level normal

6. Uncontrolled or symptomatic clinical ascites

7. Major surgical procedure within 3 weeks prior to study entry.

8. History of hypersensitivity to chemotherapy agents, contrast material.

9. Pregnancy, breast-feeding or planning to become pregnant.

10. Treatment with any investigational product in the last 4 weeks before study entry.

11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Patients of Reproductive Potential The patient must not be pregnant or breast-feeding at enrollment in the study. Absence of pregnancy must be demonstrated by serum or urine testing prior to enrollment into the study.

Female patients of child bearing potential (i.e., ovulating, premenopausal, not surgical sterile) must use a medically accepted contraceptive regimen. Male patients must agree to use a medically approved method of contraception.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Dr. Rojymon Jacob

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rojymon Jacob, MD, FRCR

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham/Department of Radiation Oncology

Derek A. Dubay, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham Department of Hepatobiliary Surgery

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F100708009

Identifier Type: -

Identifier Source: org_study_id