Comparison of SBRTand Repeat TACE for HCC (STH)

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

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

Study Overview

• Status: Unknown
• Conditions: HepatoCellular Carcinoma
• Intervention / Treatment: Radiation: SBRT

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwondo
    • Wŏnju, Gangwondo, Korea, Republic of, 25440
      • Recruiting
      • GangNeung Asan Hospital
      • Contact: Baek Gyu Jun, M.D; Phone Number: 82-10-5674-0712; Email: backyou78@hanmail.net
      • Contact: Gan Jin Cheon, M.D Ph.D.; Phone Number: 82-33-610-3018; Email: 1000@gnah.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT (Stereotatic body radiotherapy); Treatment of SBRT in HCC patients who have incomplete response after first TACE	Radiation: SBRT; Maximum dose : 60Gray (Gy) Fraction : 2 to 5; Other Names: Stereotactic Body Radiation Therapy
No Intervention: TACE (Transarterial chemoembolization); Treatment of repeated TACE in HCC patients who have incomplete response after first TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free-survival	survival from SBRT to recurrence	2 year
overall survival	survival from SBRT to death	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.	1 year

Collaborators and Investigators

• Sponsor: Gangneung Asan Hospital
• Collaborators: Soonchunhyang University Hospital
• Investigators: Study Director: Gab Jin Cheon, M.D, Ph. D, University of Ulsan College of Medicine, Gangneung Asan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: SBRT; TACE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: GNH_RT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No