Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stereotactic ablative radiotherapy

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

Group Type EXPERIMENTAL

Stereotactic ablative radiotherapy

Intervention Type RADIATION

The HCC patients with size ≤5 cm and 3 cm apart from gastrointestinal tract will be included in this study. Total stereotactic ablative radiotherapy (SABR) 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. Dose of esophagus, stomach and intestine do not exceed 30 Gy.

Interventions

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Stereotactic ablative radiotherapy

The HCC patients with size ≤5 cm and 3 cm apart from gastrointestinal tract will be included in this study. Total stereotactic ablative radiotherapy (SABR) 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. Dose of esophagus, stomach and intestine do not exceed 30 Gy.

Intervention Type RADIATION

Other Intervention Names

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Stereotactic body radiotherapy

Eligibility Criteria

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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