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Completed

NCT Number: NCT01850667

Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dongnam Institute of Radiological & Medical Sciences, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stereotactic body radiotherapy

Radiation

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)

Other names: Stereotactic ablative radiotherapy

Primary outcomes

  1. Treatment related toxicity-free survival

    Time frame: 1 year

    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

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

    From the date of SBRT to the date of death or last follow-up

  2. Progression free survival

    Time frame: 2 years

    From the date of SBRT to the date of first failure or last follow-up

  3. Intrahepatic recurrence free survival

    Time frame: 2 years

    From the date of SBRT to the date of Intrahepatic recurrence or last follow-up

  4. Patterns of failure

    Time frame: 2 years

    Patterns of failure (local, intrahepatic, or systemic)

  5. Systemic failure free survival

    Time frame: 2 years

    From the date of SBRT to the date of systemin failure or last follow-up

  6. Local control rate

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Korea Cancer Center Hospital

Other

Collaborators

  • Dongnam Institute of Radiological & Medical Sciences
  • Incheon St.Mary's Hospital
  • Inha University Hospital
  • Inje University
  • Soonchunhyang University Cheonan Hospital
  • Soonchunhyang University Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
May 9, 2013
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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