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Comparison of SBRTand Repeat TACE for HCC (STH)

Primary Purpose

HepatoCellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SBRT
Sponsored by
Gangneung Asan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HepatoCellular Carcinoma focused on measuring TACE, SBRT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gangneung Asan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SBRT (Stereotatic body radiotherapy)

TACE (Transarterial chemoembolization)

Arm Description

Treatment of SBRT in HCC patients who have incomplete response after first TACE

Treatment of repeated TACE in HCC patients who have incomplete response after first TACE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

progression free-survival
survival from SBRT to recurrence
overall survival
survival from SBRT to death
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.

Full Information

First Posted
April 24, 2017
Last Updated
October 25, 2017
Sponsor
Gangneung Asan Hospital
Collaborators
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03326375
Brief Title
Comparison of SBRTand Repeat TACE for HCC
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gangneung Asan Hospital
Collaborators
Soonchunhyang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HepatoCellular Carcinoma
Keywords
TACE, SBRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
open labled
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT (Stereotatic body radiotherapy)
Arm Type
Experimental
Arm Description
Treatment of SBRT in HCC patients who have incomplete response after first TACE
Arm Title
TACE (Transarterial chemoembolization)
Arm Type
No Intervention
Arm Description
Treatment of repeated TACE in HCC patients who have incomplete response after first TACE
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
Maximum dose : 60Gray (Gy) Fraction : 2 to 5
Primary Outcome Measure Information:
Title
Local tumor control (efficacy fo SBRT)
Description
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 Outcome Measure Information:
Title
progression free-survival
Description
survival from SBRT to recurrence
Time Frame
2 year
Title
overall survival
Description
survival from SBRT to death
Time Frame
2 year
Title
Radiation induced liver disease (RILD)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baek Gyu Jun, M.D
Phone
+82-10-5764-0712
Email
backyou78@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gab Jin Cheon, M.D, Ph. D
Organizational Affiliation
University of Ulsan College of Medicine, Gangneung Asan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gangneung Asan Hospital
City
Wŏnju
State/Province
Gangwondo
ZIP/Postal Code
25440
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baek Gyu Jun, M.D
Phone
82-10-5674-0712
Email
backyou78@hanmail.net
First Name & Middle Initial & Last Name & Degree
Gan Jin Cheon, M.D Ph.D.
Phone
82-33-610-3018
Email
1000@gnah.co.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of SBRTand Repeat TACE for HCC

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