Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Korea Cancer Center Hospital

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: Stereotactic ablative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01825824

K-1205-001-005 (Other Identifier)

KCT0000454 (Registry Identifier)

KROG 12-02 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

54 participants in 1 patient group

Stereotactic ablative radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic ablative radiotherapy