Comparison of SBRTand Repeat TACE for HCC

Gangneung Asan Hospital80 enrolled

Overview

Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE

The aim of this study is to evaluate the effect of SBRT after first incomplete TACE. In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HepatoCellular Carcinoma

Interventions

SBRTRADIATION

Maximum dose : 60Gray (Gy) Fraction : 2 to 5

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>18 years * Eastern cooperative oncology group(ECOG) score 0 to 2 * Primary HCC * HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm) * Child-Turgottei-Pugh A or B * Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined. * No evidence of radiologically definable major vascular invasion or extrahepatic disease * Previously incomplete TACE with radiologically defined residual disease after first TACE * Informed consent Exclusion Criteria: * Prior TACE to the target lesion * Contraindication to receiving radiotherapy or TACE * Decompensated liver cirrhosis * Extrahepatic mets * Pregnancy * Patients with other cancers

Locations (1)

Gangneung Asan Hospital

Wŏnju, Gangwondo, South Korea

RECRUITING

Outcomes

Primary Outcomes

Local tumor control (efficacy fo SBRT)

To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions. Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months.

Time frame: 1 year

Secondary Outcomes

progression free-survival

survival from SBRT to recurrence

Time frame: 2 year

overall survival

survival from SBRT to death

Time frame: 2 year

Radiation induced liver disease (RILD)

Liver toxicities were evaluated using Common Terminology Criteria of Adverse Events (CTCAE). RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT.

Time frame: 1 year

Central Contacts

Baek Gyu Jun, M.D

CONTACT

+82-10-5764-0712 backyou78@hanmail.net

Data from ClinicalTrials.gov

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