Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Chlorotrianisene

Liver Extracts

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.)

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.

Stereotactic Body Radiation Therapy (SBRT)

Rojymon Jacob, MD, FRCR

Derek A. Dubay, MD

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.

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.

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

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

Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.

Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.

Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.

Assess overall survival (OS) of patients treated with TACE \& SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.

Assess local failure patterns of patients treated with TACE \& SBRT. This is assessed by the percentage of patients where recurrence occurred

University of Alabama at Birmingham

Assistant Professor

Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.

Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.

TACE + SBRT

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Rojymon Jacob, MD

Safety of a Combination Therapy

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.)

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.

Spots Global Cancer Trial Database for radiation induced liver disease (rild)