Comparison of SBRTand Repeat TACE for HCC

NCT03326375 | Unknown DMC

• 1 other identifier: GNH_RT-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

HepatoCellular Carcinoma

Keywords

TACE; SBRT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• progression free-survival

  2 year

• overall survival

  2 year

• Radiation induced liver disease (RILD)

  1 year

Study Arms (2)

SBRT (Stereotatic body radiotherapy)

EXPERIMENTAL

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

Radiation: SBRT

TACE (Transarterial chemoembolization)

NO INTERVENTION

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

Interventions

SBRT RADIATION

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

Also known as: Stereotactic Body Radiation Therapy

SBRT (Stereotatic body radiotherapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior TACE to the target lesion
• Contraindication to receiving radiotherapy or TACE
• Decompensated liver cirrhosis
• Extrahepatic mets
• Pregnancy
• Patients with other cancers

Sponsors & Collaborators

• Gangneung Asan Hospital: lead
• Soonchunhyang University Hospital: collaborator

Study Sites (1)

Gangneung Asan Hospital

Wŏnju, Gangwondo, 25440, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gab Jin Cheon, M.D, Ph. D

  University of Ulsan College of Medicine, Gangneung Asan Hospital

  STUDY DIRECTOR

Central Study Contacts

Baek Gyu Jun, M.D

CONTACT

+82-10-5764-0712; backyou78@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open labled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: October 31, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)