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Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

NCT01825824 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-09-20

No results posted yet for this study

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 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.

Conditions

Interventions

RADIATION

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.

Sponsors & Collaborators

  • Dongnam Institute of Radiological & Medical Sciences

    collaborator OTHER

  • Soonchunhyang University Hospital

    collaborator OTHER

  • Inje University

    collaborator OTHER

  • Inha University Hospital

    collaborator OTHER

  • Incheon St.Mary's Hospital

    collaborator OTHER

  • Korea Cancer Center Hospital

    lead OTHER

Principal Investigators

  • Mi-Sook Kim, MD, PhD · Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-06-30
Completion
2020-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825824 on ClinicalTrials.gov