Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma

August 22, 2022 updated by: Yonsei University

Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma: Phase II Trial

Oligometastasis is a definition that has been described in the past in the 1990s, and in some patients, metastases are not extensive and are limited to a small number of metastases. The local ablative treatment for oligometastasis is not a new concept. In case of liver metastasis from colorectal cancer, long-term survival can be expected if the liver resection is performed. Effectiveness has been demonstrated in studies of adrenal and brain metastasis from lung cancer as well as lung metastasis from sarcoma. A recent non-randomized study reported that patients with oligometastasis improved treatment outcomes with aggressive treatment. This study demonstrated that local ablative treatment for oligometastasis showed better treatment outcomes than expected. Also, the long-term outcomes in SABR-COMET trial showed that the overall survival were increased by 22 months. So far, the standard treatment for metastatic disease is systemic chemotherapy. However, based on these results from studies, active local treatment for patients with oligometastasis is currently being performed in the clinic. In this study, we aimed to apply this concept to patients with hepatocellular carcinoma. To confirm the efficacy and safety of stereotactic radiotherapy in patients with oligometastasis hepatocellular carcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

i. 19 years or older

ii. Patients who signed the informed consent form

iii. The clinical trial protocol can be complied with at the discretion of the investigator

iv. Performance status (based on ECOG) less than 2 (0, 1)

v. Patients with life expectancy greater than 3 months

vi. Condition in which primary cancer is controlled

• Definition: A condition that has not progressed at the time of review of clinical trials after curative treatment of primary cancer 3 months ago

vii. Number of metastatic lesions up to 5

viii. 3 or less metastatic lesions in one metastatic organ

ix. Those who are undergoing targeted therapy or chemotherapy can also be included (during radiation therapy, drug treatment is stopped)

Exclusion Criteria:

i. Serious medical complications that cannot proceed with radiation therapy

ii. Previous radiation therapy history at the location where radiation therapy is to be performed

iii. malignant pleural effusion

iv. When the spinal cord and the tumor are close (the tumor is located within 3 mm)

v. In case of brain metastasis requiring surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT arm
Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma
Radiation: Radiation: Stereotactic body radiotherapy (SBRT)

Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma.

  1. Target delineation The GTV is set using diagnostic CT, MRI, PET-CT, etc. CTV is delineated including the microscopic range in GTV and internal margin using 4D-CT. The PTV is expanded by considering the uncertainty of the daily patient posture setting and placement.

  2. Radiotherapy All patients are treated using 3D-CRT, IMRT, or VMAT. Total dose and fractionations will be determined depending on the location and character of the metastasized tumor. Detailed radiation prescriptions is summarized in the following paragraph.

    i. Liver: 48-60 Gy in 4 fractions ii. Lung: 45-60 Gy in 3-4 fractions iii. Brain: 27-30 Gy in 3-5 fractions iv. bone: 24-40 Gy in 3-5 fractions v. adrenal gland: 30-60 Gy in 3-8 fractions vi. other organ: depending on the clinicians' decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficacy (Overall survival)
Time Frame: 2 year
The overall survival of patients from the start date of SBRT to either date of death or date of last follow up is evaluated
2 year
Treatment efficacy (Disease free survival)
Time Frame: 2 year
The disease free survival from the start date of SBRT to date of disease progression or date of death or date of last follow up is evaluated
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events (acute and late toxicity) as assessed by CTCAE v4.0
Time Frame: 2 year
The acute and late treatment-related toxicity are evaluated.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jinsil Seong, Department of radiation oncology, Yonsei cancer center, Yonsei University College of Medicine,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

September 27, 2023

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2021-1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In case that individual participant data is being shared, the study protocol is planned to be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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