Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

NCT01825824 | Unknown Phase 2

• 3 other identifiers: K-1205-001-005KCT0000454KROG 12-02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 7

Brief Summary

The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence. Recently several small studies reported high tumor response and local control rate after stereotactic ablative radiotherapy (SABR) alone or with TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3 fractionations for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Stereotactic ablative radiotherapy; Stereotactic body radiotherapy

Outcome Measures

Primary Outcomes (1)

• Local control rate

  From the date of SABR to the date of local failure or last follow-up

  up to 1 year

Secondary Outcomes (4)

• Overall survival rate

  up to 2 years

• Progression free survival rate

  up to 2 years

• Intrahepatic recurrence free survival rate

  up to 2 years

• Treatment related toxicity

  up to 1 year

Study Arms (1)

Stereotactic ablative radiotherapy

EXPERIMENTAL

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization

Radiation: Stereotactic ablative radiotherapy

Interventions

Stereotactic ablative radiotherapy RADIATION

The HCC patients with size ≤5 cm and 3 cm apart from gastrointestinal tract will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by \>48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of \> 17 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of \> 17 Gy. Dose of esophagus, stomach and intestine do not exceed 30 Gy.

Also known as: Stereotactic body radiotherapy

Stereotactic ablative radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 20 years of age
• Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
• Unresectable HCC
• Cirrhotic status of Child Pugh class A or B7
• Eastern Cooperative Oncology Group performance status 0 or 1
• single or sum of multiple tumor ≤ 5 cm
• HCC with 3 cm apart from gastrointestinal tract
• The volume of uninvolved must be at least 700 ml
• Incomplete response after trans-arterial chemo-embolization of 1-5
• A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of stereotactic body radiation therapy (SBRT)
• No evidence of an uncontrolled lesion at any other site
• No evidence of complications of liver cirrhosis
• No evidence of uncontrolled inter-current illness
• Patient or guardian must be able to provide verbal and written informed consent

You may not qualify if:

• Patient with previous history of abdominal radiation
• Direct invasion to esophagus, stomach or colon by HCC

Sponsors & Collaborators

• Korea Cancer Center Hospital: lead
• Dongnam Institute of Radiological & Medical Sciences: collaborator
• Soonchunhyang University Hospital: collaborator
• Inje University: collaborator
• Inha University Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator

Study Sites (7)

Inje University Haeundae Paik Hospital

Busan, 612-896, South Korea

Location

Dongnam Institute of Radiological & Medical Sciences

Busan, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Catholic University Incheon St. Mary's Hospital

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

Seoul, 139-706, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Location

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

• Mi-Sook Kim, MD, PhD

  Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 8, 2013
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2020
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

KR (7)