A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma (RAD 0902)

The University of Alabama at Birmingham

Status and phase: Completed; Early Phase 1

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Combination Product: Stereotactic Body Radiation Therapy (SBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01247298

F100708009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Stereotactic Body Radiation Therapy (SBRT)

Experimental group

Description:

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.)

Treatment:

Combination Product: Stereotactic Body Radiation Therapy (SBRT)