Comparison of SBRTand Repeat TACE for HCC

HepatoCellular Carcinoma Clinical Trial

— STH  

Official title:

Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03326375
• Other study ID #: GNH_RT-001
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2017
• Last updated: October 25, 2017
• Start date: March 1, 2017
• Est. completion date: March 2021

Study information

• Verified date: October 2017
• Source: Gangneung Asan Hospital
• Contact: Baek Gyu Jun, M.D
• Phone: +82-10-5764-0712
• Email: backyou78[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HepatoCellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gangneung Asan Hospital	Wonju	Gangwondo

Sponsors (2)

Lead Sponsor	Collaborator
Gangneung Asan Hospital	Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	progression free-survival	survival from SBRT to recurrence	2 year
Secondary	overall survival	survival from SBRT to death	2 year
Secondary	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.	1 year