NCT01850667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

3.2 years

First QC Date

May 7, 2013

Last Update Submit

September 18, 2019

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaStereotactic body radiotherapyStereotactic ablative radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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. 1. Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; 2. Classic radiation induced liver disease; 3. Non-classic Classic radiation induced liver disease; 4. Worsening of Child-Turcotte-Pugh score; 5. Worsening of MELD score

    1 year

Secondary Outcomes (6)

  • Overall survival

    2 years

  • Progression free survival

    2 years

  • Intrahepatic recurrence free survival

    2 years

  • Patterns of failure

    2 years

  • Systemic failure free survival

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Stereotactic body radiotherapy

EXPERIMENTAL

Stereotactic body radiotherapy for unresectable hepatocellular carcinoma after incomplete trans-arterial chemo-embolization

Radiation: Stereotactic body radiotherapy

Interventions

Stereotactic body radiotherapyRADIATION

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)

Also known as: Stereotactic ablative radiotherapy
Stereotactic body radiotherapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative 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

May 7, 2013

First Posted

May 9, 2013

Study Start

January 1, 2012

Primary Completion

April 1, 2015

Study Completion

September 1, 2017

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

KR(7)