Comparison of SBRTand Repeat TACE for HCC

NCT ID: NCT03326375

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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HepatoCellular Carcinoma

Keywords

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TACE SBRT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open labled

Study Groups

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SBRT (Stereotatic body radiotherapy)

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

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

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

TACE (Transarterial chemoembolization)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SBRT

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

Intervention Type RADIATION

Other Intervention Names

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Stereotactic Body Radiation Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role collaborator

Gangneung Asan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gab Jin Cheon, M.D, Ph. D

Role: STUDY_DIRECTOR

University of Ulsan College of Medicine, Gangneung Asan Hospital

Locations

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Gangneung Asan Hospital

Wŏnju, Gangwondo, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Baek Gyu Jun, M.D

Role: CONTACT

Phone: +82-10-5764-0712

Email: [email protected]

Facility Contacts

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Baek Gyu Jun, M.D

Role: primary

Gan Jin Cheon, M.D Ph.D.

Role: backup

Other Identifiers

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GNH_RT-001

Identifier Type: -

Identifier Source: org_study_id