Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase II Multicenter Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Toxicity and Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850667
• Other study ID #: K-1201-001-004
• Secondary ID: KCT0000454K-1201
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: September 2017

Study information

• Verified date: September 2019
• Source: Korea Cancer Center Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 body radiotherapy (SBRT) alone or with TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable HCC after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall response rate of 73% and 2-year local control rate of 95%. They reported severe gastrointestinal toxicity of 11% because there was no normal tissue constraint for gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest levels possible. In addition, they found that the presence of gastroduodenal ulcer before SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study, we will conduct a multicenter phase II trial on maintenance of treatment results and reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of gastrointestinal tract according to gastroduodenal ulcer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients = 20 years of age

• Initially diagnosed or recurrent hepatocellular carcinoma (HCC)

• Unresectable HCC

• Inaccessible to local ablative treatment

• Cirrhotic status of Child Pugh class A or B7

• Eastern Cooperative Oncology Group performance status 0 or 1

• Tumor size < 10cm

• 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 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Stereotactic body radiotherapy
Total stereotactic Body radiotherapy (SBRT) 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. In patients without gastroduodenal ulcer on Esophagogastroduodenoscopy (EGD) before SBRT, D2ml of gastrointestinal tract should not exceed 35 Gy. In patients with gastroduodenal ulcer on EGD before SBRT, D2ml of gastrointestinal tract should exceed 28 Gy. (D2ml: minimum dose to 2 ml of gastrointestinal tract)

Locations

Country	Name	City	State
Korea, Republic of	Dongnam Institute of Radiological & Medical Sciences	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Catholic University Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Korea Cancer Center Hospital	Dongnam Institute of Radiological & Medical Sciences, Incheon St.Mary's Hospital, Inha University Hospital, Inje University, Soonchunhyang University Cheonan Hospital, Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related toxicity-free survival	From the date of SBRT to the date of treatment related toxicity or last follow-up; Treatment related toxicity will be evaluated by the following criteria.; Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Classic radiation induced liver disease; Non-classic Classic radiation induced liver disease; Worsening of Child-Turcotte-Pugh score; Worsening of MELD score	1 year
Secondary	Overall survival	From the date of SBRT to the date of death or last follow-up	2 years
Secondary	Progression free survival	From the date of SBRT to the date of first failure or last follow-up	2 years
Secondary	Intrahepatic recurrence free survival	From the date of SBRT to the date of Intrahepatic recurrence or last follow-up	2 years
Secondary	Patterns of failure	Patterns of failure (local, intrahepatic, or systemic)	2 years
Secondary	Systemic failure free survival	From the date of SBRT to the date of systemin failure or last follow-up	2 years
Secondary	Local control rate	From the date of SBRT to the date of local failure or last follow-up	2 years