Clinical trial NCT01850667: Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
Official title: Phase II Multicenter Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Toxicity and Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Stereotactic body radiotherapy
Stereotactic ablative radiotherapy
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
Collaborators: name: Dongnam Institute of Radiological & Medical Sciences
name: Soonchunhyang University Hospital
name: Inje University
name: Inha University Hospital
name: Incheon St.Mary's Hospital
First posted: 2013-05-09
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment related toxicity-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progression free survival
timeFrame: 2 years
measure: Intrahepatic recurrence free survival
timeFrame: 2 years
measure: Patterns of failure
timeFrame: 2 years
measure: Systemic failure free survival
timeFrame: 2 years
measure: Local control rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological & Medical Sciences
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Incheon
country: Korea, Republic of
facility: Catholic University Incheon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
Study officials:
affiliation: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
name: Mi-Sook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: