Comparison of SBRTand Repeat TACE for HCC

Not Applicable

• Conditions: HepatoCellular Carcinoma
• Interventions: Radiation: SBRT

• Registration Number: NCT03326375
• Lead Sponsor: Gangneung Asan Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-04-24
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-10-31
• Primary Completion: 2020-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBRT (Stereotatic body radiotherapy)	SBRT	Treatment of SBRT in HCC patients who have incomplete response after first TACE

Primary Outcome Measures

Name	Time	Method
Local tumor control (efficacy fo SBRT)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
overall survival	2 year	survival from SBRT to death
progression free-survival	2 year	survival from SBRT to recurrence
Radiation induced liver disease (RILD)	1 year	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.

Trial Locations

Locations (1)

Gangneung Asan Hospital; 🇰🇷 Wŏnju, Gangwondo, Korea, Republic of