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Hepatocellular CarcinomaPhase 2NCT01825824

Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

A Phase 2 study testing Stereotactic ablative radiotherapy in people with Hepatocellular Carcinoma, run by Korea Cancer Center Hospital at 7 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Stereotactic ablative radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
7 sitesSouth Korea
Study dates
Jun 2012to Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Dongnam Institute of Radiological & Medical Sciences

    Busan

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan

  • Catholic University Incheon St. Mary's Hospital

    Incheon

  • Inha University Hospital

    Incheon

  • Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

    Seoul, 139-706

  • Soon Chun Hyang University Hospital Seoul

    Seoul

Other trials in South Korea

About this study

Official title: Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

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.

Being tested
Stereotactic ablative radiotherapy
Keywords
Hepatocellular carcinoma, Stereotactic ablative radiotherapy, Stereotactic body radiotherapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic ablative radiotherapyRadiation

    Also called Stereotactic body 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.

Study groups in NCT01825824
Study groupRoleWhat they receive
Stereotactic ablative radiotherapyExperimentalStereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization
Receives: Radiation: Stereotactic ablative radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local control rate

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

    Measured: up to 1 year

Secondary outcomes (4)

  1. Overall survival rate

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

    Measured: up to 2 years

  2. Progression free survival rate

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

    Measured: up to 2 years

  3. Intrahepatic recurrence free survival rate

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

    Measured: up to 2 years

  4. Treatment related toxicity

    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

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2015
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01825824
Sponsor's protocol ID
K-1205-001-005
Other IDs
KCT0000454, KROG 12-02, K-1205-001-005
Status last verified
Sep 2019
First submitted
3 Apr 2013
Last updated
20 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic ablative radiotherapy in people with Hepatocellular Carcinoma, run by Korea Cancer Center Hospital at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local control rate (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01825824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.

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